Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bicuspid Aortic Valve
• Intervention / Treatment: Device: Transcatheter aortic valve replacement

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Sung-Han Yoon, M.D.; Phone Number: 3104237426; Email: Sunghan.Yoon@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Sung-Han Yoon, M.D.; Phone Number: 310-423-7426; Email: Sunghan.Yoon@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 129 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death from any cause	1 month
Death	Death from any cause	1 year
Death	Death from any cause	2 years
Death	Death from any cause	3 years
Death	Death from any cause	4 years
Death	Death from any cause	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• Yoon SH, Kim WK, Dhoble A, Milhorini Pio S, Babaliaros V, Jilaihawi H, Pilgrim T, De Backer O, Bleiziffer S, Vincent F, Shmidt T, Butter C, Kamioka N, Eschenbach L, Renker M, Asami M, Lazkani M, Fujita B, Birs A, Barbanti M, Pershad A, Landes U, Oldemeyer B, Kitamura M, Oakley L, Ochiai T, Chakravarty T, Nakamura M, Ruile P, Deuschl F, Berman D, Modine T, Ensminger S, Kornowski R, Lange R, McCabe JM, Williams MR, Whisenant B, Delgado V, Windecker S, Van Belle E, Sondergaard L, Chevalier B, Mack M, Bax JJ, Leon MB, Makkar RR; Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators. Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Sep 1;76(9):1018-1030. doi: 10.1016/j.jacc.2020.07.005.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2016
• Primary Completion (ANTICIPATED): August 15, 2028
• Study Completion (ANTICIPATED): August 15, 2028

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (ACTUAL): February 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Aortic Valve Stenosis; Heart Valve Diseases; Bicuspid Aortic Valve Disease
• Other Study ID Numbers: Pro00047203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No