Clinical trial NCT03836521: Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
Official title: The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bicuspid Aortic Valve
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 129
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Death
timeFrame: 1 month
measure: Death
timeFrame: 1 year
measure: Death
timeFrame: 2 years
measure: Death
timeFrame: 3 years
measure: Death
timeFrame: 4 years
measure: Death
timeFrame: 5 years
Secondary outcomes:
measure: Death from cardiac cause
timeFrame: 1 month
measure: Death from cardiac cause
timeFrame: 1 year
measure: Death from cardiac cause
timeFrame: 2 years
measure: Death from cardiac cause
timeFrame: 3 years
measure: Death from cardiac cause
timeFrame: 4 years
measure: Death from cardiac cause
timeFrame: 5 years
measure: Stroke
timeFrame: 1 month
measure: Stroke
timeFrame: 1 year
measure: Stroke
timeFrame: 2 years
measure: Stroke
timeFrame: 3 years
measure: Stroke
timeFrame: 4 years
measure: Stroke
timeFrame: 5 years
measure: Repeat hospitalization
timeFrame: 1 month
measure: Repeat hospitalization
timeFrame: 1 year
measure: Repeat hospitalization
timeFrame: 2 years
measure: Repeat hospitalization
timeFrame: 3 years
measure: Repeat hospitalization
timeFrame: 4 years
measure: Repeat hospitalization
timeFrame: 5 years
measure: Bleeding
timeFrame: 1 month
measure: Bleeding
timeFrame: 1 year
measure: Bleeding
timeFrame: 2 years
measure: Bleeding
timeFrame: 3 years
measure: Bleeding
timeFrame: 4 years
measure: Bleeding
timeFrame: 5 years
measure: Vascular complication
timeFrame: 1 month
measure: Vascular complication
timeFrame: 1 year
measure: Vascular complication
timeFrame: 2 years
measure: Vascular complication
timeFrame: 3 years
measure: Vascular complication
timeFrame: 4 years
measure: Vascular complication
timeFrame: 5 years
measure: Acute kidney injury (stage 2 or 3)
timeFrame: 1 month
measure: Acute kidney injury (stage 2 or 3)
timeFrame: 1 year
measure: Acute kidney injury (stage 2 or 3)
timeFrame: 2 years
measure: Acute kidney injury (stage 2 or 3)
timeFrame: 3 years
measure: Acute kidney injury (stage 2 or 3)
timeFrame: 4 years
measure: Acute kidney injury (stage 2 or 3)
timeFrame: 5 years
measure: Prosthetic regurgitation by Doppler echocardiography
timeFrame: at discharge
measure: Prosthetic regurgitation by Doppler echocardiography
timeFrame: 1 month
measure: Prosthetic regurgitation by Doppler echocardiography
timeFrame: 1 year
measure: Prosthetic regurgitation by Doppler echocardiography
timeFrame: 2 years
measure: Prosthetic regurgitation by Doppler echocardiography
timeFrame: 3 years
measure: Prosthetic regurgitation by Doppler echocardiography
timeFrame: 4 years
measure: Prosthetic regurgitation by Doppler echocardiography
timeFrame: 5 years
measure: Mean aortic valve gradient by Doppler echocardiography
timeFrame: 1 month
measure: Mean aortic valve gradient by Doppler echocardiography
timeFrame: 1 year
measure: Mean aortic valve gradient by Doppler echocardiography
timeFrame: 2 years
measure: Mean aortic valve gradient by Doppler echocardiography
timeFrame: 3 years
measure: Mean aortic valve gradient by Doppler echocardiography
timeFrame: 4 years
measure: Mean aortic valve gradient by Doppler echocardiography
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References:
citation: 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.