Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE) (CALIBRATE)

CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Regurgitation; Aortic Root Aneurysm
• Intervention / Treatment: Device: Free Margin Cusp Sizer

Detailed Description

Goal of the study :

The objective of this study is to study the safety and reliability of a new surgical instrument, the "Free Margin Cusp Sizer" (patented device). The measuring instrument will be used during aortic valve repair procedures to measure the length of the free edge of the aortic cusps.

State of the art :

Currently, aortic valve repair is done by visual estimation and requires a great level of experience from the surgeon. We proposed to develop an objective cusp repair technique based on the measurement of the free edge by a dedicated sizer. The measuring instrument will give the objective difference in millimeters between the normal cusp and the one with prolapse. This will then be quantitatively plicatured to correct its excess length. This new technique will allow less experienced surgeons or those in the process of learning objective guidance of valve repair. The objective measure of the free edge length may also orient the sizing of the Dacron graft used for valve sparing root replacement.

Study evaluation criteria:

• Hospital mortality (mortality at 30 days), MACCE at one year: mortality, cerebrovascular accident or transient ischemic attack, major hemorrhage, cardiac reoperation
• Echocardiographic results at discharge from hospital and at 6 months or one year

Material and methods:

• Single-center, prospective, non-randomized study
• Patient source: Patients operated for aortic valve repair or aortic valve sparing surgery at Cliniques Universitaires Saint-Luc (CUSL), Brussels

• Number of patients to be included: 80, study duration: 4 years, inclusion period: 3 years, follow-up:

  1 year

• Inclusion criteria: patient with a tricuspid aortic valve operated electively for aortic valve insufficiency or dilation of the ascending aorta
• Exclusion criteria: acute aortic dissection, diffuse aortic valve calcification, endocarditis, bicuspide, unicuspid or quadricuspid aortic valve, patient under 18 and over 80

Data acquisition and patient follow-up:

The examinations carried out within the framework of this study are the same as those carried out routinely during the preoperative cardiac assessment and clinical follow-up after aortic valve repair:

• Preoperative cardiovascular examination including TTE (transthoracic ultrasound) / TEE (transesophageal ultrasound)
• Intraoperative TEE pre and post aortic valve repair
• TTE at discharge
• TTE between 6 months and one year postoperatively
• 1 month post-operative consultation (outpatient surgery)
• Consultation 1 to 2 months postoperative (referring cardiologist)
• Consultation 6-12 months postoperative (referring cardiologist) (if necessary, phone contact with the patient at 12-14 months)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent de Kerchove, MD, PhD; Phone Number: +32 2 764 41 51; Email: laurent.dekerchove@uclouvain.be
• Study Contact Backup: Name: Corinne Coulon; Phone Number: +32 2 764 6108; Email: corinne.coulon@uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques universitaires Saint-Luc
    • Contact: Laurent de Kerchove; Phone Number: +3227644151; Email: laurent.dekerchove@uclouvain.be
    • Contact: Corinne Coulon; Phone Number: +3227646108; Email: corinne.coulon@uclouvain.be
    • Principal Investigator: Laurent de Kerchove

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 aortic valves;
• Patients under the age of 18 years;
• Patients above the age of 80 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Free Margin Cusp Sizer; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-repair free margin length	Length of the 3 leaflets free margin before aortic valve repair	Intraoperative

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Laurent de kerchove, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Eur J Cardiothorac Surg. 2020 Jan 1;57(1):206.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: aortic valve repair; Valve sparing surgery; Trileaflet aortic valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency; Aneurysm
• Other Study ID Numbers: CALIBRATE TRIAL01; 2020-14DEC/619 (Other Identifier: Ethics Committee, Cliniques Universitaires Saint-Luc, UCL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No