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

Conditions

Aortic Stenosis

Keywords

SAPIEN 3 THV, TAVI, Transfemoral, Transaortic, Transapical, Aortic valve

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.

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.

Giuseppe Tarantini, Luca Nai Fovino, P. Le Prince, Olivier Darremont, Marina Ureña et al. (13 authors)

Circulation Cardiovascular Interventions2020-06-2544 citations

10.1161/circinterventions.120.008972

Valve hemodynamic performance and myocardial strain after implantation of a third-generation, balloon-expandable, transcatheter aortic valve

Sara Fernández-Santos, Alexis Théron, Philippe Pîbarot, Frédéric Collart, Martine Gilard et al. (9 authors)

Cardiology Journal2019-05-208 citations

10.5603/cj.a2019.0049

One-Year Outcomes of a European Transcatheter Aortic Valve Implantation Cohort According to Surgical Risk

Giuseppe Tarantini, Thierry Lefèvre, Christian Juhl Terkelsen, Christian Frerker, Patrick Ohlmann et al. (10 authors)

Circulation Cardiovascular Interventions2019-01-0117 citations

10.1161/circinterventions.118.006724

Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry.

Frank D, Abdel-Wahab M, Gilard M, Digne F, Souteyrand G, Caussin C, Collart F, Letocart V, Wöhrle J, Kuhn C, Hovorka T, Baumgartner H.

2018-12-1412 citations

10.1007/s00392-018-1404-2

SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve

Olaf Wendler, Gerhard Schymik, Hendrik Treede, Helmut Baumgartner, Nicolas Dumonteil et al. (9 authors)

European Heart Journal2017-05-21121 citations

10.1093/eurheartj/ehx294

Interventions

DEVICETAVI (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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
All cause mortality	30 days

Countries

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

Outcome results

None listed