Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Bicuspid Aortic Valve Clinical Trial

Official title:

The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03836521
• Other study ID #: Pro00047203
• Status: Recruiting
• Start date: August 15, 2016
• Est. completion date: August 15, 2028

Study information

• Verified date: February 2019
• Source: Cedars-Sinai Medical Center
• Contact: Sung-Han Yoon, M.D.
• Phone: 3104237426
• Email: Sunghan.Yoon[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 15, 2028
• Est. primary completion date: August 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 129 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Bicuspid Aortic Valve
• Heart Valve Diseases

Intervention

Device:
• Transcatheter aortic valve replacement

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death from any cause	1 month
Primary	Death	Death from any cause	1 year
Primary	Death	Death from any cause	2 years
Primary	Death	Death from any cause	3 years
Primary	Death	Death from any cause	4 years
Primary	Death	Death from any cause	5 years
Secondary	Death from cardiac cause	Death from cardiac cause	1 month
Secondary	Death from cardiac cause	Death from cardiac cause	1 year
Secondary	Death from cardiac cause	Death from cardiac cause	2 years
Secondary	Death from cardiac cause	Death from cardiac cause	3 years
Secondary	Death from cardiac cause	Death from cardiac cause	4 years
Secondary	Death from cardiac cause	Death from cardiac cause	5 years
Secondary	Stroke	disabling and non-disabling stroke	1 month
Secondary	Stroke	disabling and non-disabling stroke	1 year
Secondary	Stroke	disabling and non-disabling stroke	2 years
Secondary	Stroke	disabling and non-disabling stroke	3 years
Secondary	Stroke	disabling and non-disabling stroke	4 years
Secondary	Stroke	disabling and non-disabling stroke	5 years
Secondary	Repeat hospitalization	Number of hospitalizations	1 month
Secondary	Repeat hospitalization	Number of hospitalizations	1 year
Secondary	Repeat hospitalization	Number of hospitalizations	2 years
Secondary	Repeat hospitalization	Number of hospitalizations	3 years
Secondary	Repeat hospitalization	Number of hospitalizations	4 years
Secondary	Repeat hospitalization	Number of hospitalizations	5 years
Secondary	Bleeding	Life-threatening or major bleeding rate	1 month
Secondary	Bleeding	Life-threatening or major bleeding rate	1 year
Secondary	Bleeding	Life-threatening or major bleeding rate	2 years
Secondary	Bleeding	Life-threatening or major bleeding rate	3 years
Secondary	Bleeding	Life-threatening or major bleeding rate	4 years
Secondary	Bleeding	Life-threatening or major bleeding rate	5 years
Secondary	Vascular complication	Major vascular complication	1 month
Secondary	Vascular complication	Major vascular complication	1 year
Secondary	Vascular complication	Major vascular complication	2 years
Secondary	Vascular complication	Major vascular complication	3 years
Secondary	Vascular complication	Major vascular complication	4 years
Secondary	Vascular complication	Major vascular complication	5 years
Secondary	Acute kidney injury (stage 2 or 3)		1 month
Secondary	Acute kidney injury (stage 2 or 3)		1 year
Secondary	Acute kidney injury (stage 2 or 3)		2 years
Secondary	Acute kidney injury (stage 2 or 3)		3 years
Secondary	Acute kidney injury (stage 2 or 3)		4 years
Secondary	Acute kidney injury (stage 2 or 3)		5 years
Secondary	Prosthetic regurgitation by Doppler echocardiography		at discharge
Secondary	Prosthetic regurgitation by Doppler echocardiography		1 month
Secondary	Prosthetic regurgitation by Doppler echocardiography		1 year
Secondary	Prosthetic regurgitation by Doppler echocardiography		2 years
Secondary	Prosthetic regurgitation by Doppler echocardiography		3 years
Secondary	Prosthetic regurgitation by Doppler echocardiography		4 years
Secondary	Prosthetic regurgitation by Doppler echocardiography		5 years
Secondary	Mean aortic valve gradient by Doppler echocardiography		1 month
Secondary	Mean aortic valve gradient by Doppler echocardiography		1 year
Secondary	Mean aortic valve gradient by Doppler echocardiography		2 years
Secondary	Mean aortic valve gradient by Doppler echocardiography		3 years
Secondary	Mean aortic valve gradient by Doppler echocardiography		4 years
Secondary	Mean aortic valve gradient by Doppler echocardiography		5 years