Evaluation of a new device for measuring aortic valve repair
CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery
NA · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · NCT04797572
This study is testing a new tool that helps surgeons measure aortic valve parts during repairs to see if it makes the surgery safer and more effective, especially for those who are still learning.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT04797572 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and performance of the Free Margin Cusp Sizer, a new surgical instrument designed to measure the free margin length of aortic valve cusps during repair procedures. By providing objective measurements, the device aims to improve the accuracy of valve repairs, particularly for less experienced surgeons. Patients will be monitored for one year to assess clinical outcomes and echocardiographic results at various intervals. The study is a single-center, prospective, non-randomized design conducted at Cliniques Universitaires Saint-Luc.
Who should consider this trial
Good fit: Ideal candidates are patients with a tricuspid aortic valve undergoing elective surgery for aortic valve regurgitation or ascending aorta dilatation.
Not a fit: Patients with acute aortic dissection, significant valve calcification, or those with non-tricuspid aortic valves may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enhance the precision of aortic valve repairs, potentially leading to better patient outcomes.
How similar studies have performed: While similar approaches have been explored, this specific device and methodology represent a novel advancement in aortic valve repair techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation. Exclusion Criteria: * Acute aortic dissection; * Diffuse aortic valve calcification; * AV endocarditis; * Bicuspid, unicuspid or quadricuspid aortic valves; * Patients under the age of 18 years; * Patients above the age of 80 years.
Where this trial is running
Brussels
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (RECRUITING)
Study contacts
- Principal investigator: Laurent de kerchove — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Laurent de Kerchove, MD, PhD
- Email: laurent.dekerchove@uclouvain.be
- Phone: +32 2 764 41 51
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.
Conditions: Aortic Valve Regurgitation, Aortic Root Aneurysm, aortic valve repair, Valve sparing surgery, Trileaflet aortic valve