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Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

ConditionsAortic Valve RegurgitationAortic Root Aneurysm
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Free Margin Cusp Sizer

    Device

    The free margin cusp sizer will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Treated groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative aortic valve (AV) damage

Aortic valve damage caused by the cusp sizer (cusp tear or perforation), rate of conversion from AV repair to AV replacement due to the use of the cusp sizer

Time frame
30 days
2

Hospital mortality

Patient Survival status at 30 days after surgery

Time frame
30 days
3

Major adverse cardiac and cerebrovascular events (MACCE)

Mortality, stroke or transient ischemic attack, major bleeding, cardiac reintervention

Time frame
one year
4

Aortic valve function

Aortic valve regurgitation and transvalvular gradient by transthoracic echocardiography

Time frame
One year

Secondary outcomes

1

Pre-repair free margin length

Length of the 3 leaflets free margin before aortic valve repair

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Lead sponsor

Source ClinicalTrials.gov
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