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

Not Applicable

Completed

• Conditions: Aortic Valve Disease

• Registration Number: NCT02458560
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-01
• Primary Completion: 2016-08-22
• Study Completion: 2021-08-13
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
All-cause mortality rate	30 days post-index procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (27)

The Prince Charles Hospital; 🇦🇺 Brisbane, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Epworth Healthcare; 🇦🇺 Melbourne, Victoria, Australia

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Institut Hospitalier Jacques Cartier; 🇫🇷 Massy, France

CHU Pontchaillou; 🇫🇷 Rennes, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany

Charité - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

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