Clinical trial NCT02458560: CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
Official title: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: Transcatheter Aortic Valve Replacement
Aortic Stenosis
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
Collaborators: name: Medstar Health Research Institute
name: European Cardiovascular Research Center
name: University of British Columbia
First posted: 2015-06-01
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

Detailed description: This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.

Eligibility criteria: Inclusion Criteria:

1. Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate.
2. High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40.
3. NYHA ≥ II.
4. Study patient is an adult of legal consent age.
5. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.

Exclusion Criteria:

1. Acute myocardial infarction ≤ 30 days before the intended treatment.
2. Untreated clinically significant coronary artery disease requiring revascularization.
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve.
4. Mixed aortic valve disease (with predominant aortic regurgitation).

Primary outcomes:
measure: All-cause mortality rate
timeFrame: 30 days post-index procedure
Secondary outcomes:
measure: Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure.
timeFrame: 30 days
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Rennes
country: France
facility: CHU Pontchaillou
city: Toulouse
country: France
facility: Clinique Pasteur
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin
city: Bonn
country: Germany
facility: Herzzentrum Universitaet Bonn
city: Hamburg
country: Germany
facility: Asklepios Klinik St Georg
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: LMU - Klinikum der Universitaet Muenchen
city: Catania
country: Italy
facility: Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania
city: Milan
country: Italy
facility: Ospedale San Raffaele s.r.l.
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center Rotterdam
city: Utrecht
country: Netherlands
facility: Universitair Medical Center (UMC) Utrecht
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
Study officials:
affiliation: Inselspital Bern (Switzerland)
name: Prof. Windecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heart Center Hamburg (Germany)
name: Prof. Hermann Reichenspurner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tchetche D, Windecker S, Kasel AM, Schaefer U, Worthley S, Linke A, Abdel-Wahab M, Le Breton H, Sondergaard L, Spence MS, Petronio S, Baumgartner H, Hovorka T, Blanke P, Reichenspurner H. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC Cardiovasc Interv. 2019 Apr 8;12(7):673-680. doi: 10.1016/j.jcin.2019.01.231.
citation: Reichenspurner H, Schaefer A, Schafer U, Tchetche D, Linke A, Spence MS, Sondergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3127-3136. doi: 10.1016/j.jacc.2017.10.060.