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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-07

Study Completion Date

2024-08-20

Brief Summary

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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.

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Detailed Description

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

Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Edwards CENTERA THV

Transcatheter Aortic Valve Replacement (TAVR)

Intervention Type DEVICE

TAVR with the Edwards CENTERA THV System and accessories

Interventions

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Transcatheter Aortic Valve Replacement (TAVR)

TAVR with the Edwards CENTERA THV System and accessories

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No