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

March 12, 2021 updated by: Edwards Lifesciences

Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital, Skejby
  • Finland
      • Helsinki, Finland, 00100
        • Helsinki University Hospital
      • Oulu, Finland, 90029 OYS
        • Oulu University Hospital
  • France
      • Angers, France, 49100
        • CHU Angers
      • Besancon, France, 25000
        • Hôpital Jean Minjoz - Besancon
      • Bordeaux, France, 33000
        • Clinique Saint-Augustin - Bordeaux
      • Brest, France, 29609
        • CHU La Cavalle Blanche - Brest
      • Clermont Ferrand, France, 63000
        • CHU Gabriel-Montpied - Clermont Ferrand
      • Dijon, France, 21079
        • CHU Bocage - Dijon
      • Grenoble, France, 38700
        • Centre Hospitalier Universitaire de Grenoble
      • Le Chesnay, France, 78150
        • Hopital Prive Parly II - Le Chesnay
      • Le Plessis-Robinson, France, 92350
        • Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson
      • Lille, France, 59000
        • CHRU Lille
      • Lille, France, 59000
        • Polyclinique Bois - Lille
      • Lyon, France, 69002
        • Hospices Civils de Lyon
      • Lyon, France, 69002
        • Hospices Civiles de Lyon
      • Marseille, France, 13005
        • CHU la Timone - Marseille
      • Marseille, France, 13009
        • Clinique Clairval - Marseille
      • Marseille, France, 13285
        • Hopital Saint Joseph - Marseille
      • Massy, France, 91300
        • Institut Hospitalier Jacques Cartier Massy
      • Nancy, France, 54000
        • C.H.U. de Nancy
      • Neuilly Sur Seine, France, 92200
        • Clinique Ambroise Pare - Neuilly
      • Paris, France, 75013
        • Ch Pitie Salpetriere
      • Paris, France, 75014
        • Institut Mutualiste Montsouris - Paris
      • Paris, France, 75018
        • Hôpital Bichat Paris
      • Rouen, France, 76000
        • CHU Hopital Charles Nicolle Rouen
      • Saint-Denis, France, 93200
        • Centre Cardiologique du Nord - Saint-Denis
      • Saint-Herblain, France, 44800
        • CHU Nantes-Laennec
      • Strasbourg, France, 67000
        • CHRU Strasbourg
      • Toulouse, France, 31059
        • CHU Rangueil Toulouse
      • Tours, France, 37000
        • Clinique Saint-Gatien - Tours
  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Bad Berka, Germany, 99438
        • Zentralklinik Bad Berka GmbH
      • Bad Krozingen, Germany, 79189
        • Herz-Zentrum Bad Krozingen
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik GmbH Bad Nauheim
      • Bad Neustadt a.d.Saale, Germany, 97616
        • Herz und Gefaess Klinik - Bad Neustadt
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
      • Bad Rothenfelde, Germany, 49214
        • Schuechtermann Klinik Bad Rothenfelde
      • Bad Segeberg, Germany, 23795
        • Herzzentrum Bad Segeberg
      • Bernau, Germany, 16321
        • Immanuel Klinikum Bernau Herzzentrum Brandenburg
      • Duisburg, Germany, 47137
        • Evangelisches Klinikum Niederrhein Herzzentrum Duisburg
      • Erlangen, Germany, 91054
        • Universitaetsklinik Erlangen
      • Hamburg, Germany, 20099
        • Asklepios Klinik St Georg Hamburg
      • Hamburg, Germany, 20251
        • Universitäres Herzzentrum Hamburg
      • Karlsburg, Germany, 17495
        • KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG
      • Karlsruhe, Germany, 76133
        • Staedtisches Klinikum Karlsruhe GmbH (SKK)
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Koeln, Germany, 50937
        • Uniklinik Koeln - Herzzentrum
      • Leipzig, Germany, 4289
        • Herzzentrum Leipzig GmbH
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • Mainz, Germany, 55131
        • Johannes Gutenberg Universitaet Mainz
      • Muenchen, Germany, 80636
        • Deutsches Herzzentrum Muenchen (DHM)
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Regensburg, Germany, 93053
        • Universitaetsklinikum Regensburg
      • Siegburg, Germany, 53721
        • Helios Klinikum Siegburg
      • Stuttgart, Germany, 70376
        • Robert-Bosch Hospital Stuttgart
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Italy
      • Milano, Italy, 20132
        • Ospedale San Raffaele Milano
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino Milano
      • Palermo, Italy, 90127
        • Azienda A.R.N.A.S. Ospedale Civico di Palermo
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
  • Slovakia
      • Bratislava, Slovakia, 83348
        • Narodny ustav srdcovych a cievnych chorob, a. s.
  • Spain
      • San Sebastián, Spain, 20014
        • Policlinica Gipuzkoa Hospital
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitaetsspital Basel
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Zuerich, Switzerland, 8027
        • Klinik im Park Zuerich
      • Zuerich, Switzerland, 8032
        • HerzKlinik Hirslanden HKH - Zuerich
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elisabeth Hospital Birmingham
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Hospital NHS Foundation Trust
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • London, United Kingdom, SE17EH
        • St. Thomas Hospital London
      • London, United Kingdom, SE5 9RS
        • King´s College Hospital London
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital Plymouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from severe aortic stenosis. Inclusion criteria are based on the decision of the Heart Team.

Description

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 or vegetation
  • Active infection or endocarditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Prof. Dr. Olaf Wendler, MD, King's College Hospital, London
  • Principal Investigator: Prof. Dr. Alec Vahanian, MD, Hopital Bichat, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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