Trial record 1 of 1 for:
International long-term follow-up study of patients implanted with a Portico
5 Year Observation of Patients With PORTICO Valves (PORTICO-1)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01802788 |
|
Recruitment Status :
Active, not recruiting
First Posted : March 1, 2013
Last Update Posted : February 18, 2020
|
Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study will further assess the performance and safety profile of the commercially available Portico Valve implanted, using the Delivery System and the Loading System, in patients with severe symptomatic aortic stenosis through 5 years of follow-up.
| Condition or disease | Intervention/treatment |
|---|---|
| Aortic Valve Stenosis | Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant |
This is an international multicenter, prospective, non-randomized clinical investigation without concurrent or matched control, designed to assess the mid-term safety and performance of the Portico valve in patients with severe symptomatic aortic stenosis whom are high risk for surgical valve replacement. The primary endpoint is 1 year all-cause mortality. In addition, the performance and safety profile of the Portico valve will be further evaluated at 30 days, 1 year, and annually through 5 years post-implant.
The investigation will be conducted at approximately 65 centers in approximately 15 countries in Europe, Middle-East, Africa, Canada, Australia and New Zealand.
| Study Type : | Observational |
| Estimated Enrollment : | 1050 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve |
| Study Start Date : | April 2013 |
| Actual Primary Completion Date : | September 25, 2018 |
| Estimated Study Completion Date : | August 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Supravalvular aortic stenosis
| Group/Cohort | Intervention/treatment |
|---|---|
|
Cohort A
Patients implanted with a Portico valve bearing the CE mark (implanted after St Jude Medical declared the device "compliant" with all applicable essential requirements within the European union and marketed the device bearing the CE mark.)
|
Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant Other Names:
|
|
Cohort B
Patients implanted with a Portico valve as part of an Investigational Device study.
|
Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant Other Names:
|
Primary Outcome Measures :
- All-cause Mortality [ Time Frame: 1 year ]Death rate for any reason at 1 year
Secondary Outcome Measures :
- All Cause Mortality [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]Death rate for any reason at specified times
- Frequency of Cardiovascular Mortality as defined by the Valve Academic Research Consortium (VARC) [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
Any one of the following criteria:
- Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure).
- Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
- All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure.
- All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse event.
- Sudden or witnessed death.
- Death of unknown cause.
- Frequency of Myocardial Infarction as defined by VARC [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
Please refer to the following publication for a detailed description of this and all further VARC defined endpoints:
Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document. The Journal of Thoracic and Cardiovascular Surgery 2013;145(1):6-23.
- Frequency of Stroke as defined by VARC. [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]Rate of stroke at each time point according to the Valve Academic Research Consortium definitions.
- Frequency of Bleeding events as defined by VARC. [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]Rate of minor, major and life threatening bleeding events at each time point according to the Valve Academic Research Consortium definitions.
- Frequency of Acute Kidney injury as defined by VARC [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]Rate of AKI at each time point according to the Valve Academic Research Consortium definitions.
- Frequency of Vascular and access related complications as defined by VARC [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]Rate of major and minor VASC events at each time point according to the Valve Academic Research Consortium definitions.
- Frequency of Conduction disturbances and cardiac arrythmias as defined by VARC. [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]In particular this includes the rate of pacemaker implantation at 30 days post procedure
- Frequency of other TAVI related complications as defined by VARC. [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
- Conversion to open surgery
- Unplanned use of cardiopulmonary bypass (CPB)
- Coronary obstruction
- Ventricular septal perforation
- Mitral valve apparatus damage or dysfunction
- Cardiac tamponade
- Endocarditis
- Valve thrombosis
- Valve malpositioning
- Transcatheter valve in Transcatheter valve deployment
- Prosthetic valve function as defined by VARC [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
- Prosthetic valve stenosis
- Prosthetic valve regurgitation
- VARC defined "device success" composite endpoint [ Time Frame: 30 days ]
- Absence of procedural mortality AND
- Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
- Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
- VARC defined "Early Safety" composite endpoint [ Time Frame: 30 days ]
- All-cause mortality
- All stroke (disabling and non-disabling)
- Life-threatening bleeding
- Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
- Coronary artery obstruction requiring intervention
- Major vascular complication
- Valve-related dysfunction requiring repeat procedure (Balloon Aortic Valvuloplasty (BAV), Trans Catheter Aortic Valve Implant (TAVI), or Surgical Aortic Valve Replacement (SAVR))
- VARC defined "Clinical Efficacy" composite endpoint [ Time Frame: From 30 days post procedure to completion of follow up at 5 years. ]
- All-cause mortality
- All stroke (disabling and non-disabling)
- Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
- NYHA (New york Heart Association) class III or IV functional classification of heart failure.
- Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation.
- VARC defined "Time-related valve safety" composite endpoint [ Time Frame: From device implant to completion of follow up at 5 years. ]
- Structural valve deterioration
- Valve-related dysfunction (mean aortic valve gradient
- ≥20 mmHg, EOA ≤0.9-1.1 cm2cand/or DVI <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
- Requiring repeat procedure (TAVI or SAVR)
- Prosthetic valve endocarditis
- Prosthetic valve thrombosis
- Thrombo-embolic events (e.g. stroke)
- VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)
- New York Heart Association (NYHA) Functional classification of heart failure. [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years ]Change in NYHA class between baseline and each follow-up
- Six minute walk test (6MWT) [ Time Frame: Change between baseline and 30 days, 6 months, 1, 2, 3, 4 and 5 years ]Distance in metres that the participant can walk in 6 minutes.
- Quality of Life Assessment. [ Time Frame: Change in Quality of Life from Baseline to 30 days, 6 months, 1, 2, 3, 4 and 5 years ]Quality of life is quantified using the EQ-5D-5L questionnaire.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients that are candidates for implantation of a St Jude Medical Portico replacement aortic heart valve, or have been implanted with with a St. Jude Medical Portico valve as part of a previous investigational device trial
Criteria
Inclusion Criteria:
- Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
- Patient has been referred for a Portico Valve implant as per Heart Team decision.
- Patient has senile degenerative aortic stenosis with an initial valve area of less than (<) 1.0 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2) AND a mean transvalvular gradient greater than (>) 40mmHg or jet velocity greater than (>) 4.0 m/s derived by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LVEF) < 50%]. (Baseline measurement taken by echo within 45 days of index procedure).
- Patient has a life expectancy more than (>) 12 months.
Exclusion Criteria:
- Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any "off-label" use).
- Patient has any other than tricuspid valve.
- Patient has a prosthetic valve or ring in the aortic position.
- Patient needs a concomitant structural heart procedure.
- Patient needs the usage of an embolic protection device.
- Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
- Patient is pregnant
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802788
Locations
Show 61 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
| Principal Investigator: | Lars Søndergaard, DMSc | Rigshopitalet University Hospital, Copenhagen | |
| Principal Investigator: | Francesco Maisano, MD | Universitätsspital Zürich | |
| Principal Investigator: | Stephen Worthley | St Andrews Hospital | |
| Principal Investigator: | Josep Rodes-Cabau | Institut de Cardiologie de Quebec (Hospital Laval) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Abbott Medical Devices |
| ClinicalTrials.gov Identifier: | NCT01802788 |
| Other Study ID Numbers: |
CV-12-054-EU-PV |
| First Posted: | March 1, 2013 Key Record Dates |
| Last Update Posted: | February 18, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Abbott Medical Devices:
|
Aortic Stenosis Heart Valve Prosthesis Trans Catheter Aortic Valve Replacement |
TAVR Trans Catheter Aortic Valve Implant TAVI |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |