NCT03836521
Recruiting
Not Applicable
The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
ConditionsBicuspid Aortic Valve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bicuspid Aortic Valve
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Death
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
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.
Investigators
Raj Makkar
Profssor of Medicine, University of California
Cedars-Sinai Medical Center
Eligibility Criteria
Inclusion Criteria
- •Age≥18 years.
- •Severe aortic stenosis with bicuspid anatomy.
- •NYHA≥2 and/or syncope and/or angina.
- •Patient judged by the Heart Team as indicated for TAVR.
Exclusion Criteria
- •Age \<18 years
- •Asymptomatic patients
- •Pure aortic regurgitation.
Outcomes
Primary Outcomes
Death
Time Frame: 5 years
Death from any cause
Secondary Outcomes
- Repeat hospitalization(5 years)
- Acute kidney injury (stage 2 or 3)(5 years)
- Mean aortic valve gradient by Doppler echocardiography(5 years)
- Bleeding(5 years)
- Vascular complication(5 years)
- Prosthetic regurgitation by Doppler echocardiography(5 years)
- Death from cardiac cause(5 years)
- Stroke(5 years)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Bicuspid Valve Aortopathy Feasibility StudyBicuspid Aortic ValveNCT01920815Oregon Health and Science University500
Not yet recruiting
Not Applicable
NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International ExperienceBicuspid Aortic ValveNCT06375590Didier TCHETCHE150
Recruiting
Not Applicable
A Multicentre Retrospective Study on Bicuspid Aortic ValveBicuspid Aortic ValveNCT05818722The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1,000
Active, not recruiting
Not Applicable
International Bicuspid Aortic Valve Consortium (BAVCon)Bicuspid Aortic Valve DiseaseThoracic Aortic Disease in Patients With a Bicuspid Aortic ValveNCT01980797Boston University10,000
Recruiting
Not Applicable
Investigation of ascending aortic expansion rate in patients with bicuspid aortic valve (surgical intervention) and bicuspid valve without surgical interventioBicuspid aortic valveJPRN-UMIN000040843Saitama Cardiovascular and Respiratory Center150