Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797572
Status:
RECRUITING
Last Update Posted:
2023-05-03
First Post:
2021-03-10
Brief Title:
Clinical Evaluation of the Free Margin Cusp Sizer CALIBRATE
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALIBRATE
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-14DEC619 | OTHER | Ethics Committee Cliniques Universitaires Saint-Luc UCL | None |