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Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study (SAPIEN3)

This study is ongoing, but not recruiting participants.
C5 Research (Cleveland Clinical Coordinating Center for Clinical Research)
European Cardiovascular Research Center
University of British Columbia
Information provided by (Responsible Party):
Edwards Lifesciences Identifier:
First received: March 7, 2013
Last updated: June 12, 2015
Last verified: June 2015
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.

Condition Intervention
Aortic Valve Disease
Device: Edwards SAPIEN 3 Transcatheter Heart Valve

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve

Resource links provided by NLM:

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • All-cause mortality rate [ Time Frame: 30 days post-index procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    device success

    absence of procedural mortality AND correct positioning of a single THV and intended performance of the THV

    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 compo-site of valve structural deterioration composite of all-cause mortality, all stroke, re-hospitalization for valve-related symptoms or worsening CHF rehospitalization for valve cause NYHA class 6 MWT QoL Hospital length of stay

    echocardiography endpoints

    PVL & total valve regurgitation prosthetic valve dysfunction IEOA mean aortic valve gradient structural valve deterioration LVEF

Estimated Enrollment: 250
Study Start Date: January 2013
Estimated Study Completion Date: June 2019
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Edwards SAPIEN 3 Transcatheter Heart Valve
    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).
    Other Names:
    • TAVR
    • TAVI
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.

Ages Eligible for Study:   75 Years and older   (Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01808287

Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1 Y6
Canada, Quebec
Laval, Institut universitaire de cardiologie et de pneumologie de Quebec
Laval, Quebec, Canada, G1V4G5
Massy, Institut Jacques Cartier
Massy, France, 91300
Paris, Hopital Bichat
Paris, France, 75018
CHU Charles Nicolle
Rouen, France, 76031
CHU Rangueil
Toulouse, France, 31059
Kerckhoff Heartcenter
Bad Nauheim, Germany, 61231
Universitatsklinik Essen
Essen, Germany, 45122
Universitares Herzzentrum Hamburg GmbH
Hamburg, Germany, 20251
Stadtisches Klinikum Kalsruhe
Karlsruhe, Germany, 76133
Universitatsklinik Koln
Koln, Germany, 50937
Policlinico Universitario
Padova, Italy, 35128
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
London St. Thomas's Hospital
London, United Kingdom, SE1 7EH
King's College Hospital
London, United Kingdom, SE5 9RS
The London Heart Hospital
London, United Kingdom, W1G 8PH
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Edwards Lifesciences
C5 Research (Cleveland Clinical Coordinating Center for Clinical Research)
European Cardiovascular Research Center
University of British Columbia
Principal Investigator: John Webb, MD St. Paul's Hospital Vancouver (Canada)
Principal Investigator: Prof. Thomas Walther, MD Kerkhoff Heartcenter Bad Nauheim (Germany)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Edwards Lifesciences Identifier: NCT01808287     History of Changes
Other Study ID Numbers: 2012-07 
Study First Received: March 7, 2013
Last Updated: June 12, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Health and Medicines Authority
Canada: Health Canada

Keywords provided by Edwards Lifesciences:
Transcatheter Aortic Valve Replacement
Aortic Stenosis processed this record on January 17, 2017