Clinical trial NCT05189886: Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty
Official title: Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Keywords: TAVR
Balloon Valvuloplasty
Lead sponsor: Community Memorial Health System
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient with moderate to severe aortic regurgitation requiring replacement of his/her aortic valve.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Valve area
timeFrame: Immediately following the procedure
measure: Valve area
timeFrame: At 30 days follow up
measure: Mean gradient
timeFrame: Immediately following the procedure
measure: Mean gradient
timeFrame: At 30 days follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Community Memorial Hospital
state: California
Study officials:
affiliation: Community Memorial HealthCenter
name: Jennifer Wan, MD
role: PRINCIPAL_INVESTIGATOR
References: