Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03424941
Study type Interventional
Source Maatschap Cardiologie Zwolle
Contact Sonja Postma, PhD
Phone +31 384262999
Email TCW.trial@diagram-zwolle.nl
Status Recruiting
Phase N/A
Start date April 1, 2018
Completion date June 1, 2021

See also
  Status Clinical Trial Phase
Suspended NCT02202434 - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement N/A
Recruiting NCT03029026 - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Recruiting NCT02903420 - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Phase 3
Terminated NCT02629328 - CardioCel Tri-leaflet Repair Study N/A
Completed NCT02306226 - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Completed NCT01676727 - ADVANCE Direct Aortic N/A
Withdrawn NCT01648309 - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation N/A
Completed NCT01422044 - Risk Prediction in Aortic Stenosis N/A
Withdrawn NCT00774657 - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography N/A
Terminated NCT00535899 - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) N/A
Recruiting NCT03314857 - Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Recruiting NCT02841917 - Reactive Oxygen Species Following Aortic Valve Replacement N/A
Recruiting NCT02597985 - Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis N/A
Active, not recruiting NCT01876420 - The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study Phase 3
Recruiting NCT01736956 - Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome N/A
Completed NCT02688153 - EDWARDS INTUITY Valve System CADENCE Study N/A
Completed NCT02174471 - Regression of Myocardial Fibrosis After Aortic Valve Replacement N/A
Completed NCT01187329 - The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose N/A
Completed NCT00805051 - Acquired Von Willebrand Syndrome in Severe Aortic Stenosis N/A
Active, not recruiting NCT03250806 - Early Detection of Aortic Stenosis in the Community During Flu Vaccination