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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High risk population | Experimental | SAPIEN 3 transcatheter heart valve was implanted in high risk patients |
|
| Intermediate risk population | Experimental | SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards SAPIEN 3 Transcatheter Heart Valve | Device | The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR). |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality rate | NAP | 30 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| safety endpoints(VARC II) | safety endpoints composite of mortality, and major complications including THV-related dysfunction major bleeds MI new conduction abnormality new onset of AF time-related valve safety composite of valve structural deterioration | Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure. |
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Inclusion Criteria:
Severe symptomatic calcific aortic valve stenosis with:
Age ≥ 75 years
NYHA ≥ II
Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Webb, MD | St. Paul's Hospital Vancouver (Canada) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1 Y6 | Canada | ||
| Laval, Institut universitaire de cardiologie et de pneumologie de Quebec |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27290682 | Result | Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefevre T, Spence MS, Redwood S, Kahlert P, Rodes-Cabau J, Leipsic J, Webb J. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. EuroIntervention. 2016 Jun 12;12(2):e235-43. doi: 10.4244/EIJV12I2A37. | |
| 25456759 | Derived |
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|
| Laval |
| Quebec |
| G1V4G5 |
| Canada |
| Massy, Institut Jacques Cartier | Massy | 91300 | France |
| Paris, Hopital Bichat | Paris | 75018 | France |
| CHU Charles Nicolle | Rouen | 76031 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| Kerckhoff Heartcenter | Bad Nauheim | 61231 | Germany |
| Universitatsklinik Koln | Cologne | 50937 | Germany |
| Universitatsklinik Essen | Essen | 45122 | Germany |
| Universitares Herzzentrum Hamburg GmbH | Hamburg | 20251 | Germany |
| Stadtisches Klinikum Kalsruhe | Karlsruhe | 76133 | Germany |
| Policlinico Universitario | Padova | 35128 | Italy |
| Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
| London St. Thomas's Hospital | London | SE1 7EH | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Barts Health NHS Trust Hospital | London | W1G 8PH | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014 Dec 2;64(21):2235-43. doi: 10.1016/j.jacc.2014.09.026. Epub 2014 Nov 24. |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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