Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve

Conditions
-----------------
Aortic Valve Disease

Intervention / Treatment
-----------------
* Device: Edwards SAPIEN 3 Transcatheter Heart Valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe symptomatic calcific aortic valve stenosis with: High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients), High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150). 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). 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: Non-calcified aortic valve Acute myocardial infarction ≤ 30 days before the intended treatment Untreated clinically significant coronary artery disease requiring revascularization. Aortic valve is a congenital unicuspid or congenital bicuspid valve. Mixed aortic valve disease (with predominant aortic regurgitation) Preexisting bioprosthetic valve or ring in any position For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High risk population<br>SAPIEN 3 transcatheter heart valve was implanted in high risk patients | Device: Edwards SAPIEN 3 Transcatheter Heart Valve<br>* 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).<br>* Other names: TAVI;|
| Experimental: Intermediate risk population<br>SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients | Device: Edwards SAPIEN 3 Transcatheter Heart Valve<br>* 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).<br>* Other names: TAVI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality rate | NAP | 30 days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Stenosis, Transcatheter Aortic Valve Replacement