Aortic Valve Clinical Trials

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Partner 3 Trial

Principal Investigator: Martin B Leon, MD, FACC

The purpose of the Partner 3 Trial is to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR). Patients will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Registries for  bicuspid aortic valves, failing bioprosthetic aortic valves and failing bioprosthetic mitral valves.  Additional information including inclusion/exclusion criteria on clinicaltrials.gov

Sponsored by Edwards Lifesciences

ClinicalTrials.gov

For more information, please contact Marian Hawkey, RN at mh2403@cumc.columbia.edu

 

Early TAVR Trial

Principal Investigator: Susheel K. Kodali, MD

The purpose of the Early TAVR Trial is to establish the safety and effectiveness of the Edwards SAPIEN 3  Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or CS. Patients will be stratified by whether or not they are able to perform a treadmill stress test. In addition, patients who are screened for enrollment but have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable. Additional information including inclusion/exclusion criteria on clinicaltrials.gov

Sponsored by Edwards Lifesciences

ClinicalTrials.gov

For more information, please contact Marian Hawkey, RN at mh2403@cumc.columbia.edu

 

TAVR-Unload

Principal Investigator: Susheel K. Kodali, MD

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate aortic stenosis as compared with optimal heart failure therapy (OHFT). International, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of TAVR with the SAPIEN 3 THV and OHFT versus OHFT in HF patients, with moderate aortic stenosis.  Additional information including inclusion/exclusion criteria on clinicaltrials.gov

Sponsored by the Cardiovascular Research Foundation

ClinicalTrials.gov

For more information, please contact Marian Hawkey, RN at mh2403@cumc.columbia.edu

 

Reflect Trial

Principal Investigator: Tamim M. Nazif, MD

The objective of this study is to assess the safety and efficacy of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI. This prospective, single-blind, randomized, multicenter safety and efficacy trial will enroll up to 285 evaluable subjects and up to 90 roll-in subjects at up to 30 total investigational sites in the United States, Europe, and Israel, including up to 20 sites in the United States. Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 2:1 (stratified by study site) to one of two treatment arms: Intervention – TAVI with the TriGuard HDH embolic deflection device OR Control – standard unprotected TAVI. Additional information including inclusion/exclusion criteria on clinicaltrials.gov

Sponsored by Keystone Heart

For more information, please contact Marian Hawkey, RN at mh2403@cumc.columbia.edu

 

WATCH-TAVR Trial

Principal Investigator: Martin B Leon, MD, FACC

The objective of this study is to evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR). WATCH-TAVR is a prospective, multicenter, randomized event-driven controlled trial. Only centers with approval for commercial WATCHMAN implantation will be included in this trial. Subjects will be enrolled at approximately 25 centers in the United States. There will be up to 312 subjects enrolled, with 156 patients being randomized to TAVR + medical therapy and 156 patients randomized to simultaneous TAVR+WATCHMAN to accumulate the 191 primary events needed. Patients with non-valvular AF undergoing standard of care TAVR will be enrolled in the trial. All patients will receive anticoagulation with warfarin and aspirin for 6 weeks after the procedure.  After 6 weeks, patients randomized to the medical therapy arm will be treated indefinitely with warfarin if possible. For patients who received the WATCHMAN device, plan of care will follow WATCHMAN labeling. All patients will continue to receive routine post-TAVR follow-up and care. Additional information including inclusion/exclusion criteria on clinicaltrials.gov

Sponsored by Cleveland Clinic

ClinicalTrials.gov

For more information, please contact Marian Hawkey, RN at mh2403@cumc.columbia.edu