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

This study is currently recruiting participants.
Verified September 2013 by Edwards Lifesciences
Sponsor:
Collaborators:
Medstar Health Research Institute
European Cardiovascular Research Center
University of British Columbia
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01808287
First received: March 7, 2013
Last updated: September 27, 2013
Last verified: September 2013
  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: 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 ]
    NAP


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 prostetic valve dysfunction IEOA mean aortic valve gradient structural valve deterioration LVEF



Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: June 2019
Estimated 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 (interme-diate or higher operable risk) with severe aortic stenosis re-quiring aortic valve replacement (AVR).
    Other Names:
    • TAVR
    • TAVI
Detailed Description:

This is a non-randomized, prospective, multi-center safety and device success study. One hundred fifty (150) patients are planned to be enrolled at up to 15 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
Genders Eligible for Study:   Both
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. Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (subse-quent 100 patients).
  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, nitinol (nickel or titanium)
  21. Any neurologic disease which severely affects the ability to walk or perform everyday activities
  22. Senile dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808287

Contacts
Contact: Jodi Akin, MSN 949-250-2730 jodi_akin@edwards.com
Contact: Ishen Merioua, MD +41 44 787 4456 ihsen_merioua@edwards.com

Locations
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1 Y6
Contact: John Webb, MD    +1 604 806 8902    webb@providencehealth.bc.ca   
Principal Investigator: John Webb, MD         
France
CHU Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Helene Eltchaninoff, MD    +33 2 32 88 86 25    helene.eltchaninoff@chu-rouen.fr   
Principal Investigator: Helene Eltchaninoff, MD         
CHU Rangueil Recruiting
Toulouse, France, 31059
Contact: Nicolas Dumonteil, MD    +33561323548    dumonteil.n@chu-toulouse.fr   
Principal Investigator: Nicolas Dumonteil, MD         
Germany
Kerckhoff Heartcenter Recruiting
Bad Nauheim, Germany, 61231
Contact: Prof. Dr. Thomas Walther, MD    +49 6032 996 2501    T.Walther@kerckhoff-klinik.de   
Principal Investigator: Prof. Dr. Thomas Walther, MD         
Universitatsklinik Essen Recruiting
Essen, Germany, 45122
Contact: Matthias Thielmann, MD       Matthias.Thielmann@uk-essen.de   
Principal Investigator: Matthias Thielmann, MD         
Universitares Herzzentrum Hamburg GmbH Recruiting
Hamburg, Germany, 20251
Contact: Hendrick Treede, MD    +49 40 7410 58949    treede@uke.de   
Principal Investigator: Hendrick Treede, MD         
Stadtisches Klinikum Kalsruhe Recruiting
Karlsruhe, Germany, 76133
Contact: Gerhard Schymik, MD    +49 721 974 29 10    gerhard.schymik@klinikum-karlsruhe.de   
Principal Investigator: Gerhard Schymik, MD         
Universitatsklinik Koln Recruiting
Koln, Germany, 50937
Contact: Thorsten Wahlers, MD    +49221 478 32507    thorsten.wahlers@uk-koeln.de   
Principal Investigator: Thorsten Wahlers, MD         
Italy
Policlinico Universitario Recruiting
Padova, Italy, 35128
Contact: Giuseppe Tarantini, MD    +39 049821 2585    giuseppe.tarantini.1@unipd.it   
Principal Investigator: Giuseppe Tarantini, MD         
United Kingdom
Royal Victoria Hospital Recruiting
Belfast, United Kingdom, BT12 6BA
Contact: Mark Spence, MD    +44 7710475449    marks.spence@belfasttrust.hscni.net; markspence1@yahoo.co.uk   
Principal Investigator: Mark Spence, MD         
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Olaf Wendler, MD    +44 203 299 4341    olaf.wendler@gstt.nhs.uk   
Principal Investigator: Olaf Wendler, MD         
London St. Thomas's Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Martyn Thomas, MD    +44 207 188 10 97    martyn.thomas@gstt.nhs.uk; mttwins@aol.com   
Principal Investigator: Martyn Thomas, MD`         
The London Heart Hospital Recruiting
London, United Kingdom, W1G 8PH
Contact: Michael Mullen, MD    +44 207 504 8801    MichaeI.Mullen@uclh.nhs.uk   
Principal Investigator: Michael Mullen, MD         
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Dalrymple-Hay, MD    +44 1752 439231    malcolm@dalrymple-hay.com   
Principal Investigator: mple-Hay, MD         
Sponsors and Collaborators
Edwards Lifesciences
Medstar Health Research Institute
European Cardiovascular Research Center
University of British Columbia
  More Information

No publications provided

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: September 27, 2013
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

ClinicalTrials.gov processed this record on April 14, 2014