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The TransCatheter Valve and Vessels Trial | Clinical Trials | Clareo Health

COMPLETEDNA

The TransCatheter Valve and Vessels Trial

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

NCT03424941•Maatschap Cardiologie Zwolle

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

70 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (20)

Medical University of Graz

Graz, Austria

General Hospital Vienna

Vienna, Austria

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

CHU de Bordeaux

Bordeaux, France

CHRU de Lille

Lille, France

Clinique Pasteur

Toulouse, France

Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH

Hamburg, Germany

Onassis Cardiac Surgery Center

Kallithea, Greece

OLVG

Amsterdam, Netherlands

UMCG

Groningen, Netherlands

Key Dates

Start Date

May 31, 2018

Primary Completion Date

June 26, 2024

Completion Date

June 26, 2024

Last Updated

January 9, 2025

Enrollment

172

ACTUAL participants

Conditions

Aortic StenosisMulti Vessel Coronary Artery DiseaseTAVICABGPCIFractional Flow Reserve

Interventions

FFR-guided PCI and TAVI

DEVICE

CABG and SAVR

DEVICE

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

NCT07366671

TAVI(Transcatheter Aortic Valve Implantation)Aortic Valve Disease

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RECRUITINGNA

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

NCT06689839

Aortic Stenosis Treated With TAVIAortic Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The TransCatheter Valve and Vessels Trial

Inclusion Criteria

Exclusion Criteria

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

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