Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

Aortic Valve Regurgitation Clinical Trial

— CALIBRATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797572
• Other study ID #: CALIBRATE TRIAL01
• Secondary ID: 2020-14DEC/619
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Laurent de Kerchove, MD, PhD
• Phone: +32 2 764 41 51
• Email: laurent.dekerchove[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Root Aneurysm
• Aortic Valve Insufficiency
• Aortic Valve Regurgitation

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hospital mortality	Patient Survival status at 30 days after surgery	30 days
Primary	Major adverse cardiac and cerebrovascular events (MACCE)	Mortality, stroke or transient ischemic attack, major bleeding, cardiac reintervention	one year
Primary	Aortic valve function	Aortic valve regurgitation and transvalvular gradient by transthoracic echocardiography	One year
Secondary	Pre-repair free margin length	Length of the 3 leaflets free margin before aortic valve repair	Intraoperative