Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
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 assess aortic valve function.
Eligibility criteria
Qualifiers
Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.
Disqualifiers
Acute aortic dissection;
Diffuse aortic valve calcification;
AV endocarditis;
Bicuspid, unicuspid or quadricuspid aortic valves;
Trial design
Treatments tested in this trial
- Free Margin Cusp Sizer
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov