Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Recruiting

• Conditions: Bicuspid Aortic Valve

• Registration Number: NCT03836521
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-15
• Status Verified: 2019-02
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Last Update Submitted: 2019-02-07
• Study First Posted: 2019-02-11
• Last Update Posted: 2019-02-11
• Primary Completion: 2028-08-15
• Study Completion: 2028-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Age≥18 years.
2. Severe aortic stenosis with bicuspid anatomy.
3. NYHA≥2 and/or syncope and/or angina.
4. Patient judged by the Heart Team as indicated for TAVR.

Exclusion Criteria

1. Age <18 years
2. Asymptomatic patients
3. Pure aortic regurgitation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	5 years	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Repeat hospitalization	5 years	Number of hospitalizations
Acute kidney injury (stage 2 or 3)	5 years
Mean aortic valve gradient by Doppler echocardiography	5 years
Bleeding	5 years	Life-threatening or major bleeding rate
Vascular complication	5 years	Major vascular complication
Prosthetic regurgitation by Doppler echocardiography	5 years
Death from cardiac cause	5 years	Death from cardiac cause
Stroke	5 years	disabling and non-disabling stroke

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States