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Recruiting NCT03836521

Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

— Observational Bicuspid Aortic Valve

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter aortic valve replacement.
Who it may be relevant to
Registry conditions: Bicuspid Aortic Valve. Basic parameters: 19 years — 129 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Transcatheter aortic valve replacement

Primary outcome measures

  • Death [Time frame: 1 month]
  • Death [Time frame: 1 year]
  • Death [Time frame: 2 years]
  • Death [Time frame: 3 years]
  • Death [Time frame: 4 years]
  • Death [Time frame: 5 years]
Secondary outcome measures (12)
  • Death from cardiac cause [Time frame: 1 month]
  • Death from cardiac cause [Time frame: 1 year]
  • Death from cardiac cause [Time frame: 2 years]
  • Death from cardiac cause [Time frame: 3 years]
  • Death from cardiac cause [Time frame: 4 years]
  • Death from cardiac cause [Time frame: 5 years]
  • Stroke [Time frame: 1 month]
  • Stroke [Time frame: 1 year]
  • Stroke [Time frame: 2 years]
  • Stroke [Time frame: 3 years]
  • Stroke [Time frame: 4 years]
  • Stroke [Time frame: 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Cedars-Sinai Medical Center — Los Angeles

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 PMID 32854836

Identifiers

NCT: NCT03836521 · Pro00047203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗