Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty

Status Recruiting

Clinical Trial 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 "double tap", will improve flow across the valve when compared to a single inflation. The investigators hypothesize that "double tap" (1) will decrease mean gradient between first and second inflation during the procedure, (2) will decrease mean gradient on immediate post procedure and 30 day postprocedure echocardiograms when compared to mean gradient gradient after single inflation. Less obstruction indicated by lower mean gradient early after deployment may translate to improved 5 and 10 year outcomes. Furthermore, the investigators hypothesize that this small change in technique will have no effect on procedure time or complications and the change will not result in any increase in perioperative vascular complications, or new permanent pacemaker insertion. The primary objective of this study is to determine if double valve inflation during a TAVR procedure improves valve area and mean gradients as measured by echocardiogram immediately following the procedure and at 30 days follow up.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Aortic Valve Stenosis

Clinical Trial Details

NCT number	NCT05189886
Study type	Observational
Source	Community Memorial Health System
Contact	Erin Ross
Phone	8059488278
Email	eross1@cmhshealth.org
Status	Recruiting
Phase
Start date	November 10, 2021
Completion date	December 2024

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