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

Aortic Stenosis Clinical Trial

— SOURCE 3  

Official title:

Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698956
• Other study ID #: 2014-01
• Status: Completed
• Start date: July 2014
• Est. completion date: November 30, 2020

Study information

• Verified date: March 2021
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: November 30, 2020
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus
Finland	Helsinki University Hospital	Helsinki
Finland	Oulu University Hospital	Oulu
France	CHU Angers	Angers
France	Hopital Jean Minjoz - Besancon	Besancon
France	Clinique Saint-Augustin - Bordeaux	Bordeaux
France	CHU La Cavalle Blanche - Brest	Brest
France	CHU Gabriel-Montpied - Clermont Ferrand	Clermont Ferrand
France	CHU Bocage - Dijon	Dijon
France	Centre Hospitalier Universitaire de Grenoble	Grenoble
France	Hopital Prive Parly II - Le Chesnay	Le Chesnay
France	Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson	Le Plessis-Robinson
France	CHRU Lille	Lille
France	Polyclinique Bois - Lille	Lille
France	Hospices Civiles de Lyon	Lyon
France	Hospices Civils de Lyon	Lyon
France	CHU La Timone - Marseille	Marseille
France	Clinique Clairval - Marseille	Marseille
France	Hopital Saint Joseph - Marseille	Marseille
France	Institut Hospitalier Jacques Cartier Massy	Massy
France	C.H.U. de Nancy	Nancy
France	Clinique Ambroise Pare - Neuilly	Neuilly Sur Seine
France	CH Pitie Salpetriere	Paris
France	Hopital Bichat Paris	Paris
France	Institut Mutualiste Montsouris - Paris	Paris
France	CHU Hopital Charles Nicolle Rouen	Rouen
France	Centre Cardiologique du Nord - Saint-Denis	Saint-Denis
France	CHU Nantes-Laennec	Saint-Herblain
France	CHRU Strasbourg	Strasbourg
France	CHU Rangueil Toulouse	Toulouse
France	Clinique Saint-Gatien - Tours	Tours
Germany	Klinikum Augsburg	Augsburg
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Herz-Zentrum Bad Krozingen	Bad Krozingen
Germany	Kerckhoff-Klinik GmbH Bad Nauheim	Bad Nauheim
Germany	Herz und Gefaess Klinik - Bad Neustadt	Bad Neustadt a.d.Saale
Germany	Herz- und Diabeteszentrum NRW - Bad Oeynhausen	Bad Oeynhausen
Germany	Schuechtermann Klinik Bad Rothenfelde	Bad Rothenfelde
Germany	Herzzentrum Bad Segeberg	Bad Segeberg
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau
Germany	Evangelisches Klinikum Niederrhein Herzzentrum Duisburg	Duisburg
Germany	Universitaetsklinik Erlangen	Erlangen
Germany	Asklepios Klinik St Georg Hamburg	Hamburg
Germany	Universitares Herzzentrum Hamburg	Hamburg
Germany	Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG	Karlsburg
Germany	Staedtisches Klinikum Karlsruhe GmbH (SKK)	Karlsruhe
Germany	Universitaetsklinikum Schleswig Holstein Campus Kiel	Kiel
Germany	Uniklinik Koeln - Herzzentrum	Koeln
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen
Germany	Johannes Gutenberg Universitaet Mainz	Mainz
Germany	Deutsches Herzzentrum Muenchen (DHM)	Muenchen
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Universitaetsklinikum Regensburg	Regensburg
Germany	Helios Klinikum Siegburg	Siegburg
Germany	Robert-Bosch Hospital Stuttgart	Stuttgart
Germany	Universitaetsklinikum Ulm	Ulm
Italy	Centro Cardiologico Monzino Milano	Milano
Italy	Ospedale San Raffaele Milano	Milano
Italy	Azienda A.R.N.A.S. Ospedale Civico di Palermo	Palermo
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Slovakia	Narodny ustav srdcovych a cievnych chorob, a. s.	Bratislava
Spain	Policlinica Gipuzkoa Hospital	San Sebastián
Switzerland	Universitaetsspital Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	HerzKlinik Hirslanden HKH - Zuerich	Zuerich
Switzerland	Klinik im Park Zuerich	Zuerich
United Kingdom	Queen Elisabeth Hospital Birmingham	Birmingham
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	King´s College Hospital London	London
United Kingdom	St. Thomas Hospital London	London
United Kingdom	Derriford Hospital Plymouth	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Denmark,  Finland,  France,  Germany,  Italy,  Netherlands,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		30 days