Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

NCT04797572 | Recruiting

• 2 other identifiers: CALIBRATE TRIAL012020-14DEC/619
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Regurgitation; Aortic Root Aneurysm

Keywords

aortic valve repair; Valve sparing surgery; Trileaflet aortic valve

Outcome Measures

Primary Outcomes (4)

• 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

  30 days

• Hospital mortality

  Patient Survival status at 30 days after surgery

  30 days

• Major adverse cardiac and cerebrovascular events (MACCE)

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

  one year

• Aortic valve function

  Aortic valve regurgitation and transvalvular gradient by transthoracic echocardiography

  One year

Secondary Outcomes (1)

• Pre-repair free margin length

  Intraoperative

Study Arms (1)

Treated group

OTHER

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.

Device: Free Margin Cusp Sizer

Interventions

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.

Treated group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (2)

• De Kerchove L, Momeni M, Aphram G, Watremez C, Bollen X, Jashari R, Boodhwani M, Astarci P, Noirhomme P, El Khoury G. Free margin length and coaptation surface area in normal tricuspid aortic valve: an anatomical study. Eur J Cardiothorac Surg. 2018 May 1;53(5):1040-1048. doi: 10.1093/ejcts/ezx456.

  PMID: 29253123 BACKGROUND

• Tamer S, Mastrobuoni S, van Dyck M, Navarra E, Bollen X, Poncelet A, Noirhomme P, Astarci P, El Khoury G, de Kerchove L. Free margin length and geometric height in aortic root dilatation and leaflet prolapse: implications for aortic valve repair surgery. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):124-132. doi: 10.1093/ejcts/ezz132.

  PMID: 31089691 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Root Aneurysm

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Aortic Diseases

Study Officials

• Laurent de kerchove

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent de Kerchove, MD, PhD

CONTACT

+32 2 764 41 51; laurent.dekerchove@uclouvain.be

Corinne Coulon

CONTACT

+32 2 764 6108; corinne.coulon@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: March 22, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)