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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.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01808287
First received: March 7, 2013
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    NAP


Secondary Outcome Measures:
  • safety endpoints(VARC II) [ Time Frame: Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure. ]

    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



Enrollment: 250
Actual Study Start Date: January 2013
Estimated Study Completion Date: November 2019
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High risk population
SAPIEN 3 transcatheter heart valve was implanted in high risk patients
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
Experimental: Intermediate risk population
SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients
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.
  Eligibility

Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  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 ClinicalTrials.gov identifier: NCT01808287

Locations
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
France
Massy, Institut Jacques Cartier
Massy, France, 91300
Paris, Hopital Bichat
Paris, France, 75018
CHU Charles Nicolle
Rouen, France, 76031
CHU Rangueil
Toulouse, France, 31059
Germany
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
Italy
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
Barts Health NHS Trust Hospital
London, United Kingdom, W1G 8PH
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01808287     History of Changes
Other Study ID Numbers: 2012-07 
Study First Received: March 7, 2013
Last Updated: February 7, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edwards Lifesciences:
Transcatheter Aortic Valve Replacement
Aortic Stenosis

ClinicalTrials.gov processed this record on March 01, 2017