Status:
UNKNOWN
Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty
Lead Sponsor:
Community Memorial Health System
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
In this study, the investigators evaluate whether routine double inflation of the valve could have a lasting impact. The investigators hypothesize that a routine second reinflation of the balloon, or ...
Eligibility Criteria
Inclusion
- Male or female ≥18 years of age
- Diagnosis of severe native valve aortic stenosis
- Meets the standard of care indications to undergo TAVR procedure (aortic valve area \<1.0 cm2 or mean pressure gradient \>40 mmHg or peak velocity \>4.0 m/s or aortic valve area index \<0.6).
- Provided informed consent.
Exclusion
- History of prior aortic valve replacement
- Pre-existing moderate to severe aortic regurgitation
- Lacking pre-procedure echocardiogram
- Patients planning to undergo multiple valve replacements simultaneously
- Intraoperative arrhythmia
- Intraoperative hemodynamic instability
- Intraoperative complication during initial inflation (such as: aortic dissection, coronary artery occlusion, coronary artery dissection)
- At the discretion of the principal investigator, any reason that the potential subject may be unfit for participation, such as frailty.
Key Trial Info
Start Date :
November 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05189886
Start Date
November 10 2021
End Date
December 1 2024
Last Update
January 13 2022
Active Locations (1)
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1
Community Memorial Hospital
Ventura, California, United States, 93003