CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve

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.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4032
      • The Prince Charles Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3121
      • Epworth Healthcare
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• France
  • Massy, France, 91300
    • Institut Hospitalier Jacques Cartier
  • Rennes, France, 35033
    • CHU Pontchaillou
  • Toulouse, France, 31300
    • Clinique Pasteur
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Bad Segeberg, Germany, 23795
    • Segeberger Kliniken Gmbh
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin
  • Bonn, Germany, 53105
    • Herzzentrum Universitaet Bonn
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 20099
    • Asklepios Klinik St Georg
  • Karlsruhe, Germany, 76133
    • Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Munich, Germany, 80636
    • Deutsches Herzzentrum Muenchen
  • Munich, Germany, 81377
    • LMU - Klinikum der Universitaet Muenchen
• Italy
  • Catania, Italy, 95124
    • Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania
  • Milan, Italy, 20132
    • Ospedale San Raffaele S.r.l.
  • Pisa, Italy, 56124
    • Azienda Ospedaliero-Universitaria Pisana
• Netherlands
  • Amsterdam, Netherlands, 1105
    • Academisch Medisch Centrum (AMC)
  • Rotterdam, Netherlands, 3015
    • Erasmus University Medical Center Rotterdam
  • Utrecht, Netherlands, 3584
    • Universitair Medical Center (UMC) Utrecht
• New Zealand
  • Auckland
    • Grafton, Auckland, New Zealand, 1023
      • Auckland City Hospital
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single-arm	Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve; The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).; Other Names: TAVI; TAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality rate	30 days post-index procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Collaborators: University of British Columbia; Medstar Health Research Institute; European Cardiovascular Research Center
• Investigators: Principal Investigator: Prof. Hermann Reichenspurner, MD, University Heart Center Hamburg (Germany)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): August 22, 2016
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Transcatheter Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: 2014-03

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