Assessing CT Scan Measurements for Sutureless Aortic Valve Replacement
CT-scan Sizing Perceval Sutureless Valve
This study is testing if measurements from CT scans can help doctors choose the right size for a new sutureless aortic valve to improve outcomes for patients getting the Perceval valve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Cecilia Hospital Academic / other |
| Locations | 1 site (Cotignola, Ravenna) |
| Trial ID | NCT05799573 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between CT-derived measurements of the aortic annulus and early clinical outcomes in patients undergoing sutureless aortic valve replacement with the Perceval valve. The study aims to define a sizing chart for the Perceval valve based on preoperative CT-scan measurements, which is crucial for ensuring optimal valve deployment. By analyzing the dimensions obtained from cardiac CT scans, the study seeks to improve patient outcomes by preventing complications associated with improper valve sizing.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a tricuspid aortic valve requiring replacement and an ejection fraction of 40% or higher.
Not a fit: Patients with bicuspid aortic valves, significant mitral valvulopathy, or those with an ejection fraction below 40% may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sizing techniques for the Perceval valve, enhancing patient outcomes and reducing complications.
How similar studies have performed: Previous studies on transcatheter aortic valve implantation have shown success with similar CT measurement approaches, indicating potential for this methodology.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cotignola, Ravenna
- Maria Cecilia Hospital — Cotignola, Ravenna, Italy (Recruiting)
Study contacts
- Principal investigator: Elisa Mikus, MD — Maria Cecilia Hospital
- Study coordinator: Elisa Mikus, MD
- Email: emikus@gvmnet.it
- Phone: 0545/217678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.