Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty

Launched by COMMUNITY MEMORIAL HEALTH SYSTEM · Dec 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Transcatheter Aortic Valve Replacement (TAVR) for patients with a condition known as aortic valve stenosis, which means the heart's aortic valve is narrowed and doesn't open properly. The researchers want to see if performing a "double tap" technique—where the balloon used to open the valve is inflated twice instead of once—can help improve blood flow through the valve after the procedure. They believe that this extra inflation might lead to better results both right after the procedure and in the months that follow, without increasing the risk of complications.

To participate in this trial, individuals must be at least 18 years old, have severe narrowing of the aortic valve, and meet specific medical criteria to qualify for the TAVR procedure. Participants can expect to have their heart function monitored closely during and after the procedure to assess the impact of the double inflation technique. It's important to note that certain patients, such as those who have had previous heart valve surgery or have specific heart conditions, may not be eligible for this trial. Overall, this study aims to find ways to improve outcomes for patients undergoing this important heart procedure.

Gender

ALL

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.