Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve (CENTERA-1)

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

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. 34 patients have been enrolled at 4 participating investigational centers in Europe. 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): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53127
    • Herzzentrum Universitaet Bonn
  • Hamburg, Germany, 20099
    • Asklepios Klinik St Georg Hamburg
  • Leipzig, Germany, 042 89
    • Heart Center Leipzig
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
2. NYHA ≥ II.
3. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVR; with CENTERA self-expanding valve	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	Measure Description	Time Frame
All-cause mortality rate	NAP	30 days post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device success	Device success is defined as a composite of the following events: Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment). It is measured in % (favorable measures/total measures).	30 days
device success	Device success is defined as a composite of the following events: Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment). It is measured in % (favorable measures/total measures).	1 year

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Collaborators: University of British Columbia; Medstar Health Research Institute; European Cardiovascular Research Center
• Investigators: Principal Investigator: Prof. Mohr, MD, Leipzig, Rhön Herzentrum (Germany)

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): September 17, 2013
• Study Completion (Actual): August 23, 2018

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

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: 2012-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO