Clinical trial NCT01808287: Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
Official title: Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: Transcatheter Aortic Valve Replacement
Aortic Stenosis
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 250
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
5. 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. For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).

Primary outcomes:
measure: All-cause mortality rate
timeFrame: 30 days post-index procedure
Secondary outcomes:
measure: safety endpoints(VARC II)
timeFrame: Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Laval
country: Canada
facility: Laval, Institut universitaire de cardiologie et de pneumologie de Quebec
state: Quebec
city: Massy
country: France
facility: Massy, Institut Jacques Cartier
city: Paris
country: France
facility: Paris, Hopital Bichat
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Toulouse
country: France
facility: CHU Rangueil
city: Bad Nauheim
country: Germany
facility: Kerckhoff Heartcenter
city: Essen
country: Germany
facility: Universitatsklinik Essen
city: Hamburg
country: Germany
facility: Universitares Herzzentrum Hamburg GmbH
city: Karlsruhe
country: Germany
facility: Stadtisches Klinikum Kalsruhe
city: Koln
country: Germany
facility: Universitatsklinik Koln
city: Padova
country: Italy
facility: Policlinico Universitario
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: London
country: United Kingdom
facility: London St. Thomas's Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: St. Paul's Hospital Vancouver (Canada)
name: John Webb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.