Evaluation of a new device for measuring aortic valve repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.