Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty

Status unconfirmed

Conditions studied: Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT05189886

Run by

Community Memorial Health System

People needed

400

Starts

2021-11-10

Expected to finish

2024-12-01

Last updated by the study team

2022-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Community Memorial Hospital — Ventura, California, United States (enrolling)

Full record on ClinicalTrials.gov

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