| 1 |
NCT03112980 |
Recruiting |
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Intermediate Risk of Mortality |
|
- Device: Transcatheter aortic valve implantation
- Procedure: Surgical aortic valve replacement
|
Interventional |
Not Applicable |
- Universitätsklinikum Hamburg-Eppendorf
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Freedom from cardiovascular mortality
- Freedom from the composite of all-cause mortality and stroke
- (and 15 more...)
|
1600 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03112980 |
DEDICATE
DEDICATE - DZHK 6 |
DEDICATE |
May 10, 2017 |
May 2023 |
May 2023 |
April 13, 2017 |
October 18, 2017 |
|
- Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany - Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin)
Berlin, Germany - Charité Universitätsmedizin Berlin (Campus Mitte)
Berlin, Germany - (and 14 more...)
|
| 2 |
NCT02541877 |
Not yet recruiting |
Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve |
|
- Device: Down sizing valve in type-0 BAS
- Device: Standard sizing valve in type-0 BAS
- Device: Standard sizing valve in TAS
|
Interventional |
Phase 3 |
- Jian'an Wang,MD,PhD
- Second Affiliated Hospital, School of Medicine, Zhejiang University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of participants with Device success
- Changes of prosthetic valve functions
- All-cause mortality and all stroke (disabling and non-disabling)
- (and 4 more...)
|
159 |
All |
65 Years and older (Adult, Senior) |
NCT02541877 |
SAHZJU CT004 |
START |
September 2015 |
September 2018 |
September 2023 |
September 4, 2015 |
September 4, 2015 |
|
- 2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, China
|
| 3 |
NCT03051360 |
Not yet recruiting |
PCSK9 Inhibitors in the Progression of Aortic Stenosis |
|
- Drug: PCSK9 Inhibitor [EPC]
- Drug: Placebos
|
Interventional |
Phase 2 |
- Seoul National University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Progression of the Calcium score measured by cardiac CT (Agatston score) and by NaF PET
- Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs
- Mean change in Lp(a) levels between treatment arms
- (and 7 more...)
|
140 |
All |
19 Years and older (Adult, Senior) |
NCT03051360 |
PCSK9 AS |
|
June 1, 2017 |
December 31, 2019 |
January 1, 2020 |
February 13, 2017 |
February 13, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
| 4 |
NCT03483051 |
Not yet recruiting
New |
Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After TAVR for Severe Aortic Stenosis |
|
- Drug: Potassium Nitrate
- Drug: Potassium Chloride
|
Interventional |
Phase 2 |
- University of Pennsylvania
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Total work performed during a maximal-effort exercise test
- Peak Oxygen uptake (VO2) during a maximal effort exercise test
- Quality of Life score
- (and 4 more...)
|
22 |
All |
50 Years to 90 Years (Adult, Senior) |
NCT03483051 |
828994 |
PULSE AS |
April 1, 2018 |
April 1, 2020 |
April 1, 2020 |
March 29, 2018 |
March 29, 2018 |
|
|
| 5 |
NCT02727504 |
Recruiting |
Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve |
|
- Device: Electrocardiogram
- Device: 2D and 3D echocardiography
- Device: Dobutamine stress echocardiography
- (and 5 more...)
|
Observational |
|
- Rennes University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of death of all cause
- Number of emergent hospitalization for any cardiovascular reason
- Death (all causes)
- (and 3 more...)
|
115 |
All |
45 Years to 90 Years (Adult, Senior) |
NCT02727504 |
2015-A00896-43
35RC15_9884_LOWAS |
LOWAS |
May 11, 2016 |
December 2018 |
January 2019 |
April 4, 2016 |
January 23, 2018 |
|
- CHU de Rennes
Rennes, France
|
| 6 |
NCT03112629 |
Recruiting |
Study to Improve Outcomes in Aortic Stenosis |
|
|
Observational |
|
- Institut für Pharmakologie und Präventive Medizin
- Edwards Lifesciences
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals
- Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope)
- Outcomes (survival) (intervention vs. conservative treatment)
|
800 |
All |
18 Years and older (Adult, Senior) |
NCT03112629 |
Impulse enhanced |
|
March 23, 2017 |
March 31, 2019 |
June 30, 2019 |
April 13, 2017 |
June 14, 2017 |
|
- Bichat Hospital Paris
Paris, France - Department of Cardiology and Angiology, University of Kiel
Kiel, Schleswig-Holstein, Germany
|
| 7 |
NCT03411304 |
Recruiting |
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement |
|
|
Observational |
|
- University Hospital, Rouen
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Occurrence of clinical events according to left ventricular remodeling
- Evolution of left ventricular remodeling after aortic valvular replacement
- Prognostic value of persistence and type of left ventricular remodeling
- (and 2 more...)
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT03411304 |
2017/080/HP |
|
December 5, 2017 |
December 2020 |
December 2023 |
January 26, 2018 |
January 26, 2018 |
|
|
| 8 |
NCT01118442 |
Recruiting |
Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics |
|
|
Observational |
|
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
|
6 |
All |
18 Years and older (Adult, Senior) |
NCT01118442 |
1424 |
|
December 2009 |
December 2019 |
December 2019 |
May 6, 2010 |
February 8, 2017 |
|
- Imperial College NHS Trust
London, United Kingdom
|
| 9 |
NCT03471065 |
Not yet recruiting |
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis |
|
|
Interventional |
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Procedural success defined as freedom from mortality
- Number/percentage of patients who have a major vascular complication as per VARC II definition
|
30 |
All |
19 Years and older (Adult, Senior) |
NCT03471065 |
2018-03 |
|
May 2018 |
July 2018 |
July 2023 |
March 20, 2018 |
March 20, 2018 |
|
|
| 10 |
NCT01835028 |
Recruiting |
Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study) |
|
- Other: Echocardiography
- Other: Computed tomography
- Other: Magnetic resonance imaging
- (and 2 more...)
|
Observational |
|
- Laval University
- University Hospital, Brest
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- all-cause mortality
- 30-day mortality (for patients treated by SAVR or TAVR)
- cardiovascular mortality
- (and 2 more...)
|
320 |
All |
21 Years to 90 Years (Adult, Senior) |
NCT01835028 |
MOP-57745 |
|
June 2002 |
January 2018 |
January 2019 |
April 18, 2013 |
September 5, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States - Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States - Viena General Hospital
Vienna, Austria - (and 8 more...)
|
| 11 |
NCT02792452 |
Recruiting |
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis |
|
|
Observational |
|
- London North West Healthcare NHS Trust
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Death (cardiovascular/all cause)
- Hospitalisation for heart failure
- Aortic valve replacement (TAVI or surgical AVR)
- (and 2 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02792452 |
AV AS-01 |
|
September 2016 |
July 2018 |
July 2018 |
June 7, 2016 |
April 13, 2017 |
|
- Northwick Park Hospital
Harrow, MIddx, United Kingdom
|
| 12 |
NCT03411317 |
Recruiting |
Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling |
|
|
Observational |
|
- University Hospital, Rouen
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
- Determinants of left ventricular remodeling
- Progression of left ventricular remodeling
- Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT03411317 |
2017/081/HP |
AS-PROGRESSION |
December 11, 2017 |
December 2023 |
December 2023 |
January 26, 2018 |
January 26, 2018 |
|
|
| 13 |
NCT01679431 |
Recruiting |
Metabolic Determinants of the Progression of Aortic Stenosis |
|
- Other: Doppler-echocardiography
- Radiation: Computed tomography
- Other: Magnetic resonance imaging
- Biological: Fasting blood sample
|
Observational |
|
- Laval University
- Canadian Institutes of Health Research (CIHR)
- Heart and Stroke Foundation of Canada
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Progression of aortic valve stenosis
- Progression of aortic valve calcification
- Progression of myocardial fibrosis and dysfunction
|
250 |
All |
21 Years and older (Adult, Senior) |
NCT01679431 |
MOP-114997 |
PROGRESSA |
April 2005 |
January 2018 |
January 2019 |
September 6, 2012 |
March 7, 2017 |
|
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada
|
| 14 |
NCT02536703 |
Not yet recruiting |
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population |
|
- Device: Lotus Valve System
|
Interventional |
Phase 3 |
- Second Affiliated Hospital, School of Medicine, Zhejiang University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Combined rate of death from any cause, myocardial infarction, and stroke
- Number of participants with procedural complications
- Functional status (NYHA-classification)
- (and 2 more...)
|
20 |
All |
65 Years and older (Adult, Senior) |
NCT02536703 |
SAHZJU CT005 |
LOTUS-CHINA |
September 2015 |
December 2015 |
December 2020 |
September 1, 2015 |
September 1, 2015 |
|
- 2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, China
|
| 15 |
NCT02917525 |
Recruiting |
Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI |
- Aortic Valve Stenosis
- Bicuspid Aortic Valve
|
- Dietary Supplement: Vitamin K2
- Other: Placebo
|
Interventional |
Phase 2 |
- Maastricht University Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in aortic valve calcium metabolism
- Change in aortic valve calcium score
- Progression of aortic valve stenosis
|
44 |
All |
18 Years and older (Adult, Senior) |
NCT02917525 |
METC152045 |
BASIK2 |
August 2016 |
December 2019 |
December 2019 |
September 28, 2016 |
March 22, 2018 |
|
- Maastricht UMC
Maastricht, Netherlands
|
| 16 |
NCT02624934 |
Recruiting |
Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis |
|
|
Observational |
|
- Bassett Healthcare
- Baylor University
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Podocan level
- Wnt Pathway molecule levels
- 6 minute walk test
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02624934 |
2023 |
|
October 2015 |
October 2019 |
December 2019 |
December 9, 2015 |
February 2, 2017 |
|
- Bassett Healthcare Network
Cooperstown, New York, United States
|
| 17 |
NCT02436655 |
Recruiting |
Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis |
|
- Procedure: surgical aortic valve replacement
|
Interventional |
Not Applicable |
- Clinical Centre of Serbia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- all cause death, Major Adverse Cardiac Event (MACE) including: ( Acute Myocardial Infarction - AMI, Stroke - CVI, unplanned hospitalization for Heart failure (HF) needing intravenous treatment
- in-hospital and 30 days operative mortality in operated patients in both groups
- repeat aortic valve surgery in operated patients in both groups
- (and 3 more...)
|
312 |
All |
18 Years and older (Adult, Senior) |
NCT02436655 |
FWA00011929 |
AVATAR |
June 2015 |
December 2019 |
December 2020 |
May 7, 2015 |
January 23, 2018 |
|
- Cardiovascular Center Aalst
Aalst, Belgium - University Clinical Center "Rebro"
Zagreb, Croatia - University Clinical Center ''Sestre milosrdnice''
Zagreb, Croatia - (and 11 more...)
|
| 18 |
NCT03186339 |
Recruiting |
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI |
|
- Procedure: TAVI
- Procedure: SAVR
- Other: MM
|
Observational |
|
- Institut für Pharmakologie und Präventive Medizin
- Edwards Lifesciences
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in QoL as assessed by SF12 (Short Form 12) Questionnaire
- Change in QoL as assessed by KCCQ (The Kansas City Cardiomyopathy Questionnaire)
- Change in QoL as assessed by TASQ (Toronto Aortic Stenosis Quality of Life Questionnaire)
- Difference in change in QoL between arms
|
290 |
All |
18 Years and older (Adult, Senior) |
NCT03186339 |
IPPM2017TASQ |
TASQ |
September 8, 2017 |
July 15, 2018 |
September 15, 2018 |
June 14, 2017 |
November 27, 2017 |
|
- Medical University of Innsbruck
Innsbruck, Austria - University Health Network, Toronto General Hospital
Toronto, Ontario, Canada - UKSH University Clinical Center Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany - Barts Heart Centre
London, United Kingdom
|
| 19 |
NCT02627391 |
Recruiting |
Early Surgery for Patients With Asymptomatic Aortic Stenosis |
- Aortic Valve Stenosis
- Aortic Valve Surgery
|
- Other: Early surgical aortic valve replacement
- Other: Delayed Surgical aortic valve replacement
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Combination of overall mortality and cardiac morbidity
- Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity
- Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group
- (and 2 more...)
|
360 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02627391 |
AOM 140460 |
ESTIMATE |
January 2016 |
November 2018 |
November 2019 |
December 10, 2015 |
July 5, 2017 |
|
- Henri Mondor Hospital
Creteil, France
|
| 20 |
NCT01845285 |
Recruiting |
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System |
|
- Device: Aortic Valve Replacement
|
Observational |
|
- Direct Flow Medical, Inc.
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Freedom from all-cause mortality at 30 days
- Device Success (VARC defined)
- Early Safety
- (and 2 more...)
|
1000 |
All |
71 Years and older (Senior) |
NCT01845285 |
RP 001 |
DISCOVER |
March 2013 |
December 2016 |
December 2019 |
May 3, 2013 |
February 24, 2016 |
|
- Elisabeth Krankenhaus
Essen, Germany - Ospedale Niguarda Ca' Granda
Milan, Italy
|
| 21 |
NCT02675114 |
Recruiting |
The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis |
|
- Procedure: Surgical aortic valve replacement (SAVR)
- Device: Transcatheter Aortic Valve Replacement (TAVR)
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- All-cause mortality, all stroke, and re-hospitalization
- Length of index hospitalization (Device and Control group)
- Death or Stroke
|
1328 |
All |
19 Years and older (Adult, Senior) |
NCT02675114 |
2015-08 |
P3 |
March 2016 |
October 2018 |
March 2027 |
February 5, 2016 |
March 23, 2018 |
|
- University of Alabama
Birmingham, Alabama, United States - Banner University Medical Center
Phoenix, Arizona, United States - Mills/Peninsula Health Services
Burlingame, California, United States - (and 73 more...)
|
| 22 |
NCT03051334 |
Recruiting |
Ascending Aortic Dilation in BiAV After TAVR |
|
- Other: diagnosed as bicuspid aortic valve
|
Observational |
|
- Seoul National University Hospital
|
Other |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
- changes in dimension of ascending aorta
|
100 |
All |
21 Years and older (Adult, Senior) |
NCT03051334 |
1701-104-825 |
|
January 1, 2007 |
December 30, 2017 |
December 30, 2017 |
February 13, 2017 |
February 13, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
| 23 |
NCT03143361 |
Recruiting |
Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry) |
- Aortic Valve Stenosis
- Valve Heart Stenosis
|
- Procedure: Aortic valve replacement
|
Observational |
|
- University of Parma
- Universita di Verona
- University of Genova
- (and 13 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- 5-year all-cause mortality
- Follow-up all-cause mortality
- Cardiovascular mortality
- (and 25 more...)
|
8000 |
All |
18 Years and older (Adult, Senior) |
NCT03143361 |
E-AVR |
E-AVR |
November 1, 2017 |
November 2019 |
October 2029 |
May 8, 2017 |
December 27, 2017 |
|
- University of Parma
Parma, Italy
|
| 24 |
NCT03422770 |
Recruiting |
Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis |
- Aortic Valve Stenosis
- Myocardial Fibrosis
|
- Diagnostic Test: Echocardiography
- Diagnostic Test: MRI
- Diagnostic Test: Blood test
- (and 2 more...)
|
Interventional |
Not Applicable |
- Norwegian University of Science and Technology
- St. Olavs Hospital
- Oslo University Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- Cardiovascular morbidity and mortality
- All cause mortality
- Time of first re-hospitalisation
- (and 2 more...)
|
200 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT03422770 |
2017/1068 |
|
January 9, 2018 |
January 2031 |
January 2031 |
February 6, 2018 |
February 6, 2018 |
|
- Department of Circulation and Medical Imaging
Trondheim, Norway
|
| 25 |
NCT02010177 |
Recruiting |
Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in left ventricular ejection fraction after aortic valve replacement
|
100 |
All |
18 Years to 95 Years (Adult, Senior) |
NCT02010177 |
SHEBA-13-0686-IB-CTIL |
|
December 2013 |
December 2018 |
June 2019 |
December 12, 2013 |
April 24, 2018 |
|
- Sheba Medical Center
Ramat Gan, Israel
|
| 26 |
NCT01737528 |
Recruiting |
STS/ACC Transcatheter Valve Therapy Registry (TVT Registry) |
|
- Procedure: Transcatheter Aortic Valve Replacement
|
Observational |
|
- The Society of Thoracic Surgeons
- American College of Cardiology
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Major adverse cardiac and cerebrovascular events
- Mortality
|
16000 |
All |
18 Years and older (Adult, Senior) |
NCT01737528 |
TVTR-2012-01 |
TVTR |
June 2012 |
June 2018 |
June 2022 |
November 29, 2012 |
July 2, 2017 |
|
- American College of Cardiology
Washington, D.C., District of Columbia, United States
|
| 27 |
NCT02559011 |
Recruiting |
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device |
|
|
Observational |
|
- University Hospital Inselspital, Berne
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of patients with incidence of new onset atrial fibrillation and complete AVB within 12 months after TAVI
- Number of patients with resolution of atrial Fibrillation
- Number of patients with resolution of Atrium Ventricular Block (AVB) after TAVI with permanent pacemaker (PPM) implantation
- (and 5 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02559011 |
2015_09_21 |
Reveal |
March 2016 |
September 2018 |
December 2018 |
September 24, 2015 |
April 14, 2017 |
|
- Bern University Hospital, Dep. of Cardiology
Bern, Switzerland
|
| 28 |
NCT03011346 |
Recruiting |
Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis. |
|
- Device: Symetis ACURATE neo/TF transfemoral TAVI system
- Device: Edwards Sapien 3 Transcatheter Heart Valve
|
Interventional |
Not Applicable |
- University Hospital Inselspital, Berne
- Kerckhoff Heart Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Modified* combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
- Device success
- Early safety
- (and 18 more...)
|
730 |
All |
75 Years and older (Senior) |
NCT03011346 |
V 1.2, 24.11.16 |
SCOPE I |
February 8, 2017 |
December 2018 |
September 2020 |
January 5, 2017 |
March 15, 2018 |
|
- Bern University Hospital
Bern, Switzerland
|
| 29 |
NCT01755936 |
Recruiting |
The Role of Myocardial Fibrosis in Patients With Aortic Stenosis |
|
- Other: Cardiac Magnetic Resonance Imaging
- Other: Echocardiography
- Other: 72 hour Holter Monitor
|
Observational |
|
- University of Edinburgh
- British Heart Foundation
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT01755936 |
2010/R/CAR/05 |
|
January 2012 |
January 2017 |
January 2017 |
December 24, 2012 |
August 30, 2016 |
|
- University of Edinburgh
Edinburgh, Midlothian, United Kingdom
|
| 30 |
NCT03270124 |
Recruiting |
A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement |
|
- Behavioral: Daily Activity Goal
- Behavioral: Resistance Exercises
- Behavioral: Daily Activity Recording
|
Interventional |
Not Applicable |
- Vanderbilt University Medical Center
- Edwards Lifesciences
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Average Daily Activity
- 5 meter gait time
- Quality of Life as measured with the KCCQ Overall Summary Score
- (and 5 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03270124 |
ACTIVE AFTER TAVR |
|
November 7, 2017 |
September 2020 |
September 2020 |
September 1, 2017 |
April 23, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States - Atlantic Health - Morristown Medical Center
Morristown, New Jersey, United States - (and 2 more...)
|
| 31 |
NCT03442400 |
Recruiting |
A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis |
- Coronary Artery Stenoses
- Aortic Stenosis
|
- Device: Volcano iFR/FFR Verrata Plus coronary pressure/flow wire
|
Interventional |
Not Applicable |
- The Cleveland Clinic
- Volcano Corporation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- iFR/FFR
- Pd/Pa (ratio of the pressure distal to a coronary stenosis and the pressure in the aorta)
|
50 |
All |
20 Years to 110 Years (Adult, Senior) |
NCT03442400 |
IRB 17-695 |
|
February 14, 2018 |
December 31, 2018 |
December 31, 2018 |
February 22, 2018 |
February 22, 2018 |
|
- The Cleveland Clinic
Cleveland, Ohio, United States
|
| 32 |
NCT02781896 |
Recruiting |
Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI |
|
- Device: pacing catheter
- Device: valve delivery guidewire
|
Interventional |
Not Applicable |
- Groupe Hospitalier Mutualiste de Grenoble
- Centre Recherche Cardio Vasculaire Alpes
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Other
|
- Total TAVI procedural duration
- Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency)
- Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety)
- Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness)
|
300 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT02781896 |
EASY TAVI 2016 |
EASY TAVI |
May 12, 2017 |
December 2018 |
December 2018 |
May 25, 2016 |
March 29, 2018 |
|
- CHU Clermont Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes, France - Centre Hospitalier Annecy Genevois
Epagny, Auvergne-Rhône-Alpes, France - Clinique du Tonkin
Villeurbanne, Auvergne-Rhône-Alpes, France - (and 6 more...)
|
| 33 |
NCT03088787 |
Not yet recruiting |
Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis |
- Aortic Stenosis, Calcific
|
- Device: Nexfin measuremtents
|
Observational |
|
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Edwards Lifesciences
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- the distinctive morphological characteristics of the aortic pressure waveform
- changes in hemodynamic variables after TAVR and its influence on cardiac recovery.
|
100 |
All |
Child, Adult, Senior |
NCT03088787 |
W17_072 |
COaRt |
April 2017 |
October 2017 |
December 2017 |
March 23, 2017 |
March 23, 2017 |
|
|
| 34 |
NCT02448927 |
Recruiting |
The preDIlatation in tRanscathEter aortiC Valve implanTation Trial |
|
- Device: balloon aortic valvuloplasty
- Device: Transcatheter Aortic Valve Implantation
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Device success
- Death
- Cerebrovascular accident
- (and 3 more...)
|
170 |
All |
18 Years and older (Adult, Senior) |
NCT02448927 |
DIRECT Trial |
DIRECT |
May 2015 |
May 2017 |
May 2018 |
May 20, 2015 |
May 20, 2015 |
|
- First Department of Cardiology, University of Athens
Athens, Attiki, Greece - Department of Cardiology, Onassis Cardiac Surgery Center
Athens, Greece - Second Department of Cardiology, University Hospital of Ioannina
Ioannina, Greece - (and 2 more...)
|
| 35 |
NCT03029026 |
Recruiting |
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis. |
- Cardiac Amyloidosis
- Aortic Stenosis
|
- Other: Baseline assessment
- Procedure: Transthoracic echocardiography
- Procedure: 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid scintigraphy
- (and 4 more...)
|
Observational |
|
- Queen Mary University of London
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Patient mortality
- Major adverse cardiovascular events (MACE)
- Length of hospital stay
- (and 2 more...)
|
250 |
All |
75 Years and older (Senior) |
NCT03029026 |
006974 |
ATTRact-AS |
September 2016 |
April 2019 |
April 2019 |
January 24, 2017 |
April 19, 2018 |
|
- Barts Heart Centre
London, United Kingdom - The John Radcliffe Hospital
Oxford, United Kingdom
|
| 36 |
NCT03417011 |
Recruiting |
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System |
|
- Device: Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- All-cause mortality
- Total AR
- VARC-2 composite safety endpoint
- (and 6 more...)
|
600 |
All |
Child, Adult, Senior |
NCT03417011 |
MDT17050EVR003 |
|
February 26, 2018 |
May 31, 2019 |
September 30, 2024 |
January 31, 2018 |
March 26, 2018 |
|
- Hospital Universitario Central de Asturias
Oviedo, Spain - Royal Victoria Hospital - Belfast Health and Social Care Trust
Belfast, United Kingdom
|
| 37 |
NCT02664649 |
Recruiting |
Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis |
- Symptomatic Aortic Stenosis
- Eligible for Transcatheter Aortic Valve Replacement
|
- Drug: Apixaban
- Drug: Standard of care
|
Interventional |
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
- Action Research Group
- Bristol-Meyers Squibb & Pfizer
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite of death, myocardial infarction, stroke, systemic embolism, intracardiac or bioprosthesis thrombus, any episode of deep vein thrombosis or pulmonary embolism, life-threatening or disabling or major bleeding at one year follow-up.
- Presence or not of an indication (other than TAVI) for anticoagulation described in the medical record.
- First occurrence of any event of the following composite criteria: a) Death, MI, any stroke through one year of randomization, b) Death, any stroke/TIA or systemic embolism c) Each individual parameter of the primary endpoint
|
1510 |
All |
18 Years and older (Adult, Senior) |
NCT02664649 |
P141102
2015-001676-21 |
ATLANTIS |
August 26, 2016 |
April 2, 2019 |
April 2, 2019 |
January 27, 2016 |
February 23, 2017 |
|
- ACTION Study Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC
Paris, France
|
| 38 |
NCT03298178 |
Recruiting |
ASAN Medical Center Aortic Valve Replacement Registry |
|
- Procedure: TAVR
- Procedure: SAVR
|
Observational |
|
- Suk Jung Choo
- CardioVascular Research Foundation, Korea
- Asan Medical Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- All cause death
- Cardiovascular mortality
- Myocardial infarction
- (and 13 more...)
|
6000 |
All |
Child, Adult, Senior |
NCT03298178 |
AMCCV 2017-09 |
ASAN-AVR |
December 1, 2017 |
December 2030 |
December 2031 |
October 2, 2017 |
December 12, 2017 |
|
- Asan Medical Hospital
Seoul, Korea, Republic of
|
| 39 |
NCT03140735 |
Recruiting |
Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis |
- Pulse Wave
- Aortic Stenosis
|
- Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
- Other: Control group without heart disease
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire, Amiens
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
|
900 |
All |
18 Years and older (Adult, Senior) |
NCT03140735 |
PI2016_843_0035 |
VOPRABIO |
July 3, 2017 |
June 20, 2027 |
June 20, 2027 |
May 4, 2017 |
July 21, 2017 |
|
- CHU Amiens Picardie
Amiens, Picardie, France
|
| 40 |
NCT03196596 |
Recruiting |
Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI) |
|
- Other: Computer simulation
|
Observational |
|
- Erasmus Medical Center
- feops
- Cardialysis B.V.
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Decision 1- Valve size decision based on pre TAVI MSCT
- Decision 2- Valve size decision after knowledge of the computer simulation results
- Decision 3- Change of initial valve size decision during TAVI
- (and 7 more...)
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT03196596 |
TAVIguide |
TAVIguide |
May 23, 2017 |
March 2018 |
May 2018 |
June 23, 2017 |
June 23, 2017 |
|
- Universitair Ziekenhuis Antwerpen
Edegem, Belgium - Rigshospitalet
København, Denmark - CHRU La Cavale Blanche
Brest, France - (and 4 more...)
|
| 41 |
NCT03192813 |
Recruiting |
Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II |
|
- Device: Symetis ACURATE neo™ transfemoral TAVI system
- Device: Medtronic CoreValve Evolut R TAVI System
|
Observational |
|
|
Industry |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Composite of all-cause mortality or stroke rates
- New permanent pacemaker rate
- All cause mortality at 30 days
- (and 35 more...)
|
764 |
All |
75 Years and older (Senior) |
NCT03192813 |
SCOPE II |
SCOPE II |
April 20, 2017 |
April 2019 |
July 2019 |
June 20, 2017 |
February 12, 2018 |
|
- Heart Center, Rigshospitalet, University of Copenhagen
Copenhagen, Denmark - Oulun University Hospital
Oulu, Finland - CHRU Brest Cavale Blanche
Brest, France - (and 16 more...)
|
| 42 |
NCT03192774 |
Recruiting |
The Prospective Segeberg TAVI Registry |
|
- Device: Transcatheter Aortic Valve Implantation
|
Observational |
|
- Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Mortality
- Structural valve deterioration
|
2000 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT03192774 |
168/11 |
POST-TAVI |
September 2007 |
December 2022 |
December 2032 |
June 20, 2017 |
March 9, 2018 |
|
- Heart Center, Segeberger Kliniken
Bad Segeberg, Germany
|
| 43 |
NCT03107897 |
Recruiting |
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement |
|
|
Interventional |
Not Applicable |
- WellSpan Health
- Lancaster General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)
- Mobility - Timed Up and Go Test
- Four Square Step Test
- Change in Quality of Life (Kansas City Cardiomyopathy Questionnaire score)
|
70 |
All |
Child, Adult, Senior |
NCT03107897 |
TAVR Prehab |
TAVR-Prehab |
August 17, 2016 |
March 30, 2018 |
May 30, 2018 |
April 11, 2017 |
November 6, 2017 |
|
- WellSpan Gettsyburg Hospital
Gettysburg, Pennsylvania, United States - Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, United States - WellSpan York Hospital
York, Pennsylvania, United States
|
| 44 |
NCT03087552 |
Recruiting |
Mini-invasive Balloon Aortic Valvuloplasty |
|
- Procedure: Transradial balloon aortic valvuloplasty
|
Observational |
|
- University Hospital of Ferrara
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Vascular complications
- Transradial balloon aortic valvuloplasty major complications
- Adverse events
- (and 3 more...)
|
160 |
All |
18 Years and older (Adult, Senior) |
NCT03087552 |
18072011 |
SOFTLY-II |
March 11, 2017 |
June 30, 2019 |
June 30, 2020 |
March 22, 2017 |
January 3, 2018 |
|
- University Hospital of Ferrara
Cona, Ferrara, Italy
|
| 45 |
NCT03056573 |
Recruiting |
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access |
|
- Device: Subclavian or Transaortic TAVR Implant
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of major vascular complications
- All cause mortality event rates
- Cardiovascular mortality event rates
- (and 9 more...)
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT03056573 |
SJM-CIP-10144 |
Portico ALT |
March 14, 2017 |
November 2018 |
February 2019 |
February 17, 2017 |
April 20, 2018 |
|
- Rigshospitalet Copenhagen
Copenhagen, Denmark - Deutsches Herzzentrum Berlin
Berlin, Germany - Herzzentrum Leipzig GmbH
Leipzig, Germany - (and 4 more...)
|
| 46 |
NCT02989558 |
Recruiting |
A Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr With Acetylsalicylic Acid Versus CLopidogrel With Acetylsalicylic Acid in the Development of Cerebrovascular EMbolic Events During TAVI |
|
- Drug: Ticagrelor plus ASA
- Drug: Clopidogrel plus ASA
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The number of confirmed HITS, as assessed by Transcranial Doppler (TCD), between the two treatment groups during the TAVI procedure.
- The incidence of cerebral embolic events between the two treatment groups, as assessed by HITS measured by TCD at subject discharge.
- the incidence of cerebral embolic events in each treatment group, during the TAVI procedure, and at subject discharge.
- (and 2 more...)
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT02989558 |
D5130C00173 |
PTOLEMAIOS |
December 2016 |
December 2018 |
December 2018 |
December 12, 2016 |
February 24, 2017 |
|
- 1st Department of Cardiology, Hippokration Hospital
Athens, Greece
|
| 47 |
NCT02974660 |
Recruiting |
Protamine Sulfate During Transcatheter Aortic Valve Implantation |
|
- Drug: Protamine sulfate
- Drug: 0.9% NaCl
|
Interventional |
Phase 4 |
- Medical University of Warsaw
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Bleeding complications
- Successful closure of the access-site
- Thromboembolic complications
- (and 2 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT02974660 |
WUM-KZ |
PS TAVI |
December 2016 |
November 2018 |
January 2019 |
November 28, 2016 |
March 13, 2018 |
|
- First Department of Cardiology, Medical University of Warsaw
Warsaw, Poland
|
| 48 |
NCT02817789 |
Recruiting |
Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI) |
|
- Drug: Ticagrelor alone
- Drug: Combination lysine acetylsalicylate - clopidogrel
|
Interventional |
Phase 3 |
- University Hospital, Bordeaux
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of patient presenting at least one event of the Valve Academic Research Consortium-2 (VARC2) composite endpoint
- Number of patient died
- Number of patient presenting stroke or Transient Ischemic Attack (TIA)
- (and 17 more...)
|
308 |
All |
18 Years and older (Adult, Senior) |
NCT02817789 |
CHUBX 2014/24 |
TICTAVI |
May 2016 |
May 2018 |
May 2018 |
June 29, 2016 |
June 30, 2016 |
|
- CHRU de Lille
Lille, France - APHM
Marseille, France - CHRU de Nîmes
Nîmes, France - (and 2 more...)
|
| 49 |
NCT02805309 |
Recruiting |
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement |
|
- Behavioral: Exercise
- Behavioral: Cognitive behavioral interventions
- Behavioral: Attention control education program
|
Interventional |
Not Applicable |
- Brigham and Women's Hospital
- Hebrew SeniorLife
- National Institute on Aging (NIA)
- Beth Israel Deaconess Medical Center
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Change in the Late-Life Function and Disability Instrument (LLFDI) Score
- Change in the Short Physical Performance Battery (SPPB) Summary Score
- Change in the 2-Minute walk distance (meters)
- (and 2 more...)
|
60 |
All |
65 Years and older (Adult, Senior) |
NCT02805309 |
2017P000106
P30AG031679
P30AG048785 |
REHAB-TAVR |
August 1, 2017 |
August 31, 2018 |
October 31, 2018 |
June 20, 2016 |
December 20, 2017 |
|
- Hebrew SeniorLife
Boston, Massachusetts, United States - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
| 50 |
NCT02755220 |
Recruiting |
Cingularbio® Heart Valve Clincial Study |
|
- Device: Cingularbio® Aortic valve replacement
|
Interventional |
Phase 3 |
- Shanghai Cingularbio Co. Ltd
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- device related adverse valve events
|
180 |
All |
60 Years to 85 Years (Adult, Senior) |
NCT02755220 |
XZBM-2015-01 |
|
January 2016 |
December 2018 |
December 2019 |
April 28, 2016 |
April 28, 2016 |
|
- Zhongshan Hospital of Fudan University
Shanghai, Shanghai, China
|
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