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Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice. (SOURCE 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698956
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:

This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.

300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.


Condition or disease Intervention/treatment
Aortic Stenosis Device: TAVI (Transcatheter Aortic Valve Implantation)

Detailed Description:

The purpose of this registry is to provide clinical outcome and safety information on patients that will be treated with the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery devices for severe, symptomatic calcific aortic stenosis. In addition, the information collected will serve post market safety and surveillance regulatory obligations.

Consecutive patient data will be collected at baseline, procedure, discharge, after discharge (at approx. 30 days post-index procedure), 12 months post-index procedure and annually thereafter up to 5 years post-implant according to usual practice at site.

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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry.
Actual Study Start Date : July 2014
Actual Primary Completion Date : February 2016
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: TAVI (Transcatheter Aortic Valve Implantation)
    Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and Edwards Commander Delivery system (transfemoral) and Certitude Delivery system (transapical/transaortic). The Edwards S3 THV is indicated for use in patients with severe, symptomatic, calcific aortic stenosis with STS Score ≥ 8 or Logistic EuroSCORE ≥15
    Other Name: TAVR


Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. New York Heart Association Functional Classification [ Time Frame: 30 days ]
  2. Cardiovascular mortality (including any valve-related dysfunction or any valve-related adverse event [ Time Frame: 30 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from severe aortic stenosis. Inclusion criteria are based on the decision of the Heart Team.
Criteria

Inclusion Criteria:

  • Patient suffering from severe, symptomatic, calcific aortic stenosis
  • STS Score ≥ 8
  • Logistic EuroSCORE ≥15

Exclusion Criteria:

  • Congenital unicuspid or congenital bicuspid aortic valve
  • Evidence of intracardiac mass
  • Thrombus
  • Vegetation
  • Active infection or endocarditis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698956


Locations
Show Show 73 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Prof. Dr. Olaf Wendler, MD King's College Hospital, London
Principal Investigator: Prof. Dr. Alec Vahanian, MD Hopital Bichat, Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02698956    
Other Study ID Numbers: 2014-01
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edwards Lifesciences:
SAPIEN 3 THV
TAVI
Transfemoral
Transaortic
Transapical
Aortic valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction