Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
This trial is active, not recruiting.
|Condition||aortic valve disease|
|Treatment||edwards sapien 3 transcatheter heart valve|
|Collaborator||C5 Research (Cleveland Clinical Coordinating Center for Clinical Research)|
|Start date||January 2013|
|End date||December 2013|
|Trial size||250 participants|
|Trial identifier||NCT01808287, 2012-07|
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Vancouver, Canada||St. Paul's Hospital||no longer recruiting|
|Laval, Canada||Laval, Institut universitaire de cardiologie et de pneumologie de Quebec||no longer recruiting|
|Massy, France||Massy, Institut Jacques Cartier||no longer recruiting|
|Paris, France||Paris, Hopital Bichat||no longer recruiting|
|Rouen, France||CHU Charles Nicolle||no longer recruiting|
|Toulouse, France||CHU Rangueil||no longer recruiting|
|Bad Nauheim, Germany||Kerckhoff Heartcenter||no longer recruiting|
|Essen, Germany||Universitatsklinik Essen||no longer recruiting|
|Hamburg, Germany||Universitares Herzzentrum Hamburg GmbH||no longer recruiting|
|Karlsruhe, Germany||Stadtisches Klinikum Kalsruhe||no longer recruiting|
|Koln, Germany||Universitatsklinik Koln||no longer recruiting|
|Padova, Italy||Policlinico Universitario||no longer recruiting|
|Belfast, United Kingdom||Royal Victoria Hospital||no longer recruiting|
|London, United Kingdom||King's College Hospital||no longer recruiting|
|London, United Kingdom||London St. Thomas's Hospital||no longer recruiting|
|London, United Kingdom||The London Heart Hospital||no longer recruiting|
|Plymouth, United Kingdom||Derriford Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
All-cause mortality rate
time frame: 30 days post-index procedure
device success(VARC II) safety endpoints(VARC II) echocardiography endpoints(VARCII)
time frame: Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.
Male or female participants at least 75 years old.
Inclusion Criteria: 1. Severe symptomatic calcific aortic valve stenosis with: 1. High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients), 2. High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150). 3. Intermediate surgical risk: STS Score 4 to 8 or Logistic EuroSCORE 10 to 15 (subsequent patients); except for 20mm valve implants (STS Score > 4 or EuroSCORE ≥ 10) 2. Age ≥ 75 years. 3. NYHA ≥ II 4. AVA< 1cm2 and mean gradient > 40mmHg 5. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate 6. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits Exclusion Criteria: 1. Non-calcified aortic valve 2. Acute myocardial infarction ≤ 30 days before the intended treatment 3. Untreated clinically significant coronary artery disease requiring revascularization. 4. Aortic valve is a congenital unicuspid or congenital bicuspid valve. 5. Mixed aortic valve disease (with predominant aortic regurgitation) 6. Preexisting bioprosthetic valve or ring in any position 7. Leukopenia, anemia, thrombocytopenia 8. Hypertrophic cardiomyopathy with or without obstruction 9. Severe ventricular dysfunction with LVEF < 20% 10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation 11. Active upper GI bleeding within 90 days prior to procedure 12. known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure 13. Native aortic annulus size : 1. < 18 mm or > 25 mm as measured by TEE, 23 and 26mm valves 2. > 27mm as measured by TEE, 29mm valve 3. < 16mm as measured by TEE, 20mm valve 14. Clinically (by neurologist) or neuroimaging confirmed stroke or TIA within 90 days of the procedure 15. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening 16. Estimated life expectancy < 24 months 17. Expectation that patient will not improve despite treatment of aortic stenosis 18. Currently participating in an investigational drug or another device study 19. Active bacterial endocarditis within 180 days of procedure 20. Known hypersensitivity to contrast media, chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials 21. Any neurologic disease which severely affects the ability to walk or perform everyday activities 22. Senile dementia 23. For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).
|Official title||Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve|
|Principal investigator||John Webb, MD|
|Description||This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years.|
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