CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System

Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03699345

Enrollment

Registered

2018-10-09

Start date

2019-01-07

Completion date

2024-08-20

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

CENTERA, THV, Transcatheter Heart Valve

Brief summary

This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

Detailed description

A prospective, international, single arm, multi-center post market clinical follow-up study.

Interventions

DEVICETranscatheter Aortic Valve Replacement (TAVR)

TAVR with the Edwards CENTERA THV System and accessories

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Severe native valve calcific aortic stenosis * Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).

Exclusion criteria

* Known hypersensitivity to Nitinol (nickel or titanium) * Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis * Inability to tolerate anticoagulation/antiplatelet therapy

Design outcomes

Primary

Measure	Time frame	Description
All-Cause Mortality	30 days	All-cause mortality at 30 days

Countries

Denmark, France, Germany, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026