Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Recruiting
N/A
Interventional Study
Aortic Valve Regurgitation
Aortic Root Aneurysm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The objective of this study is to investigate safety and performance of the Free Margin Cusp sizer. The device will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length at different stages of the procedure. The patient will be followed for one year clinically (at 1, 2, 6 and 12 months) and by echocardiography (at 6 and 12 months) to …
Trial Locations
Loading…
Loading trial locations…
Eligibility 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 aort…
Contacts