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UnknownNCT05737264

TAVR in Adults With Pure Severe Aortic Regurgitation

Safety and Effectiveness of Transcatheter Treatment of Severe Native Aortic Regurgitation With Self-Expandable Valve Implantation: a Multicenter, Observational,Cohort Study(SENSE-AR)

Status
Unknown
Phase
Study type
Observational
Enrollment
76 (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

Summary

The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.

Conditions

Timeline

Start date
2022-12-01
Primary completion
2023-10-01
Completion
2023-10-01
First posted
2023-02-21
Last updated
2023-05-30

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05737264. Inclusion in this directory is not an endorsement.

TAVR in Adults With Pure Severe Aortic Regurgitation (NCT05737264) · Clinical Trials Directory