Recruiting

TAVR & Valvuloplasty

Sponsor:

Community Memorial Health System

Code:

NCT05189886

Conditions

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Double Balloon Valvuloplasty in TAVR

Study Details

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

Study ID

NCT05189886

Start date

Nov 10, 2021

Status verified date

Dec, 2021

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

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 measure

  • Valve area [ Time Frame: Immediately following the procedure ]
  • Valve area [ Time Frame: At 30 days follow up ]
  • Mean gradient [ Time Frame: Immediately following the procedure ]
  • Mean gradient [ Time Frame: At 30 days follow up ]

Central Contacts and Locations

Central contacts

Erin Ross

8059488278eross1@cmhshealth.org

Locations

Community Memorial Hospital

Recruiting

Ventura, California, United States, 93003

Contacts

Erin Ross

805-948-8278eross1@cmhshealth.org

More Information

Sponsor

Community Memorial Health System

Last update posted

Jan 13, 2022

Last verified

Dec, 2021

Keywords

  • TAVR
  • Balloon Valvuloplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Community Memorial Health System on 2022-01-13.