China S3 PMS: SAPIEN 3 China Post Market Registry Study

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

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-24

Study Completion Date

2035-12-31

Brief Summary

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The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.

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Detailed Description

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This is an observational, single-arm, multicentre, post-market study.

Conditions

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Aortic Stenosis, Severe

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transcatheter Aortic Valve Implantation (TAVI)

SAPIEN 3 Transcatheter Heart Valve

Intervention Type DEVICE

Implantation of the SAPIEN 3 valve

Interventions

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SAPIEN 3 Transcatheter Heart Valve

Implantation of the SAPIEN 3 valve

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment
2. All surgical risks as determined by the site Heart Team
3. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
2. Considered to be part of a vulnerable population
3. Pre-existing mechanical or bioprosthetic aortic valve
4. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
5. Cannot tolerate an anticoagulation/antiplatelet regimen
6. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
7. Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath
8. Participating in a drug or device study that has not reached its primary endpoint

Eligible Sex

ALL

Accepts Healthy Volunteers

No