CT Scan Sizing for Perceval Sutureless Valve

Launched by MARIA CECILIA HOSPITAL · Mar 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special heart valve called the Perceval sutureless valve for patients with aortic valve regurgitation, a condition where the heart's aortic valve doesn't close properly, causing blood to flow backward. The trial is looking at how to measure the size of the aortic valve accurately using a CT scan, which is a type of imaging test. This measurement is important because it helps doctors choose the right size of the valve to ensure it fits well and functions properly.

To participate in this trial, individuals must be over 18 years old and have a need for an aortic valve replacement, specifically for a type of valve called a tricuspid aortic valve. Participants should also have a heart function (ejection fraction) of at least 40% and be willing to attend follow-up appointments. However, those with certain heart conditions or other health issues, like a bicuspid aortic valve or severe kidney problems, will not be eligible. If you join the trial, you can expect to undergo a CT scan to help determine the best valve size, and you will be monitored throughout the process to ensure your safety and care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female subjects \> 18 years;
• • 2. Subjects willing to sign and date an informed consent for treatment of personal data;
• • 3. Subjects willing and able to comply with the follow up schedule of the protocol;
• • 4. Subjects with indication for aortic valve replacement on a tricuspid aortic valve;
• • 5. Subjects with possibly associated need for coronary revascularization.
• • 6. Subjects with Ejection Fraction ≥ 40%
• Exclusion Criteria:
• • 1. Male and female subjects ≤ 18 years;
• • 2. Subjects with bicuspid aortic valve
• • 3. Subjects with associated mitral valvulopathy or ascending aorta aneurysm
• • 4. Subjects with pure aortic insufficiency
• • 5. Subjects with Ejection Fraction \< 40%
• • 6. Subjects with acute myocardial infarction \< 30 gg
• • 7. Subjects with serum creatinine \> 2 mg/Dl