Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Double Balloon Valvuloplasty in TAVR

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Erin Ross; Phone Number: 8059488278; Email: eross1@cmhshealth.org

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • Recruiting
      • Community Memorial Hospital
      • Contact: Erin Ross; Phone Number: 805-948-8278; Email: eross1@cmhshealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A patient with moderate to severe aortic regurgitation requiring replacement of his/her aortic valve.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective; 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.	Procedure: 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.
Retrospective; The retrospective phase will collect data from previous TAVR procedures completed between February 2019 and October 1, 2021. Data from up to 200 patient charts will be collected using the Society of Thoracic Surgeons/American College of Cardiology that is maintained by the CMH Cardiology Department. The population will be de-identified as the purpose is to obtain descriptive information from the medical records to utilize for propensity match scoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Valve area	Valve area as measured by echocardiogram	Immediately following the procedure
Valve area	Valve area as measured by echocardiogram	At 30 days follow up
Mean gradient	Mean gradient as measured by echocardiogram	Immediately following the procedure
Mean gradient	Mean gradient as measured by echocardiogram	At 30 days follow up

Collaborators and Investigators

• Sponsor: Community Memorial Health System
• Investigators: Principal Investigator: Jennifer Wan, MD, Community Memorial HealthCenter

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: TAVR; Balloon Valvuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2021-HSR013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No