Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty

NCT05189886 | Unknown

• 1 other identifier: 2021-HSR013
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

TAVR; Balloon Valvuloplasty

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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.

Interventions

Double Balloon Valvuloplasty in TAVR PROCEDURE

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.

Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Community Memorial Health System: lead

Study Sites (1)

Community Memorial Hospital

Ventura, California, 93003, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Jennifer Wan, MD

  Community Memorial HealthCenter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Ross

CONTACT

8059488278; eross1@cmhshealth.org

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: January 13, 2022
• Study Start: November 10, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

US (1)