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

Aortic Valve Disease Clinical Trial

— CENTERA-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808274
• Other study ID #: 2012-03
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: August 23, 2018

Study information

• Verified date: November 2018
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 23, 2018
• Est. primary completion date: September 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

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).

Locations

Country	Name	City	State
Germany	Herzzentrum Universitaet Bonn	Bonn
Germany	Asklepios Klinik St Georg Hamburg	Hamburg
Germany	Heart Center Leipzig	Leipzig
Switzerland	Inselspital Bern	Bern

Sponsors (4)

Lead Sponsor	Collaborator
Edwards Lifesciences	European Cardiovascular Research Center, Medstar Health Research Institute, University of British Columbia

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality rate	NAP	30 days post-index procedure
Secondary	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
Secondary	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