CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.
Locations
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Contact Information
Primary
Laurent de Kerchove, MD, PhD
laurent.dekerchove@uclouvain.be
+32 2 764 41 51
Backup
Corinne Coulon
corinne.coulon@uclouvain.be
+32 2 764 6108
Time Frame
Start Date: 2021-03-22
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 120
Treatments
Other: Treated group
Patients in whom the free margin cusp sizer will be used to measure the free margin of the three leaflets of the aortic valve during aortic valve repair.
Related Therapeutic Areas
Sponsors
Leads: Cliniques universitaires Saint-Luc- Université Catholique de Louvain