Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty

Recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: Double Balloon Valvuloplasty in TAVR

• Registration Number: NCT05189886
• Lead Sponsor: Community Memorial Health System

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 "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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-10
• Study First Submitted: 2021-11-22
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-28
• Last Update Submitted: 2021-12-28
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Male or female ≥18 years of age
2. Diagnosis of severe native valve aortic stenosis
3. 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).
4. Provided informed consent.

Exclusion Criteria

1. History of prior aortic valve replacement
2. Pre-existing moderate to severe aortic regurgitation
3. Lacking pre-procedure echocardiogram
4. Patients planning to undergo multiple valve replacements simultaneously
5. Intraoperative arrhythmia
6. Intraoperative hemodynamic instability
7. Intraoperative complication during initial inflation (such as: aortic dissection, coronary artery occlusion, coronary artery dissection)
8. At the discretion of the principal investigator, any reason that the potential subject may be unfit for participation, such as frailty.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective	Double Balloon Valvuloplasty in TAVR	The prospective phase will enroll patients planning to undergo TAVR, at the discretion of Drs. Wan and Fatemi, and if they meet all of the inclusion criteria and none of the exclusion criteria. All patients who provide consent will undergo the TAVR procedure where the valve will be double inflated. Echocardiogram results and procedure details will be collected as data. At the patient's 30-day follow-up clinic visit, as per standard of care, they will be re-evaluated with an echocardiogram. Details from that follow-up visit and the echocardiogram results will be collected as data. Prospective enrollment will begin upon IRB approval and we plan to continue enrollment until December 31, 2023, or once 200 participants are reached, whichever comes first.

Primary Outcome Measures

Name	Time	Method
Mean gradient	At 30 days follow up	Mean gradient as measured by echocardiogram
Valve area	At 30 days follow up	Valve area as measured by echocardiogram

Trial Locations

Locations (1)

Community Memorial Hospital; 🇺🇸 Ventura, California, United States