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The TransCatheter Valve and Vessels Trial (TCW)

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ClinicalTrials.gov Identifier: NCT03424941
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : July 12, 2022
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Maatschap Cardiologie Zwolle

Study Description
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Brief Summary:
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Multi Vessel Coronary Artery Disease TAVI CABG PCI Fractional Flow Reserve Device: FFR-guided PCI and TAVI Device: CABG and SAVR Not Applicable

Detailed Description:

Prospective, randomized, controlled, open label, multicenter, international, non-inferiority trial

If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 1:1 fashion between FFR-guided PCI + TAVI and CABG + SAVR.

Patients will receive optimal medical treatment at discharge. Follow-up will be performed at 30 days and at one year. During the 30 day follow-up visit (after TAVI) patients will be evaluated for symptoms of angina.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients With Coronary MultiVessel Disease and Aortic Valve Stenosis
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FFR-guided PCI and TAVI
FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO
 Device: FFR-guided PCI and TAVI
Treatment of subjects with multivessel coronary artery disease and aortic stenosis for FFR-guided PCI and TAVI (Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO)
Active Comparator: CABG and SAVR
CABG and SAVR
 Device: CABG and SAVR
Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint is a composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year [ Time Frame: one year ]
  2. All-cause mortality and all stroke at 30 days and at one year [ Time Frame: 30 days and one year ]
  3. Life-threatening or disabling bleeding at 30 days and one year [ Time Frame: 30 days and one year ]
  4. Life-threatening or disabling bleeding and major bleeding at 30 days and at one year [ Time Frame: 30 days and one year ]
  5. Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year [ Time Frame: 30 days and one year ]
  6. Access-related complications at 30 days [ Time Frame: 30 days ]
  7. Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year [ Time Frame: 30 days and one year ]
  8. Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year [ Time Frame: 30 days and one year ]
  9. Device success (Valve Academic Research Consortium (VARC) 2 definition) [ Time Frame: procedure ]
  10. Early Safety at 30 days (VARC 2 definition) [ Time Frame: 30 days ]
  11. Early Efficacy at 30 days (VARC 2 definition) [ Time Frame: 30 days ]
  12. Time Related Valve Safety at 30 days (VARC 2 definition) [ Time Frame: 30 days ]
  13. Echocardiographic assessment of prosthetic valve performance at discharge and at one year using the following measures: a) transvalvular mean gradient, b) Effective Orifice Area (EOA), c) degree of prosthetic aortic valve regurgitation [ Time Frame: discharge and at one year ]
  14. Clinically driven revascularisation at 30 days and at one year [ Time Frame: 30 days and one year ]
  15. Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year [ Time Frame: 30 days and one year ]
  16. Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year [ Time Frame: 30 days and one year ]
  17. Quality of life (Short Form (SF)-36) before treatment and at one year [ Time Frame: one year ]

Eligibility Criteria
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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.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Symptomatic patients aged ≥70 years with aortic stenosis fulfilling one of these criteria (Aortic Valve Area (AVA) ≤1 cm2; mean gradient ≥40 mmHg; Aortic jet velocity >4 m/sec; or Velocity index ≤ 0.25) feasible for treatment by both trans femoral or subclavian approach TAVI as well as conventional SAVR and where the Heart Team decides that treatment is needed (final decision is left to the Heart Team)
  2. Presence of ≥2 de novo coronary lesions of ≥50% diameter stenosis on visual estimation located in any of main epicardial coronary arteries, or side branches of a lumen caliber of more than 2 mm or single Left Anterior Descending (LAD) lesion with more than 20 mm length or involving a bifurcation (complex), feasible for treatment with CABG as well as PCI (Heart Team decision)
  3. Patients willing and capable to provide written informed consent

Exclusion Criteria:

  1. Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics <48 hours before procedure
  2. Left ventricular ejection fraction <30%
  3. Concomitant presence of other than aortic valve disease requiring intervention
  4. Previous CABG, SAVR, TAVI or thoracotomy for any other reason
  5. Bicuspid or unicuspid aortic valve
  6. Recent myocardial infarction (less than 2 weeks)
  7. Involvement of left main trifurcation (all three branches being larger than 2 mm)
  8. Expected total stent length more 60mm per vessel
  9. FFR measurement judged impossible
  10. Life expectancy <1 year
  11. Known malignancy
  12. Contraindication for dual antiplatelet therapy or expected surgical intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the first 6 months
  13. Reduced renal function (Glomerular Filtration Rate (GFR) <29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
  14. Previous disabling stroke, Transient Ischemic Attack (TIA) in the last 6 months, or known severe stenosis of carotid or vertebral arteries
  15. Participation in other investigational clinical trials
Contacts and Locations
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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): NCT03424941


Contacts
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Contact: Sonja Postma, PhD +31 384262999 TCW.trial@diagram-zwolle.nl

Locations
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Sponsors and Collaborators
Maatschap Cardiologie Zwolle
Medtronic
Investigators
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Principal Investigator: prof. Elvin Kedhi, MD, PhD Hopital Erasme, Brussels, Belgium
More Information
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Responsible Party: Maatschap Cardiologie Zwolle
ClinicalTrials.gov Identifier: NCT03424941    
Other Study ID Numbers: 9283
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maatschap Cardiologie Zwolle:
Aortic Stenosis (AS)
Multi Vessel Coronary Artery Disease (MVD)
TransCatheter Aortic Valve Implantation (TAVI)
Coronary Artery By-pass Grafting (CABG)
 Percutaneous Coronary Intervention (PCI)
Fractional Flow Reserve (FFR)
Surgical Aortic Valve Replacement (SAVR)
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction