Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557616
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation in a Single-arm Non-randomised Open-label Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoolCryo
Brief Summary:
The study involves endocardial cryoablation of the left andor right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery with the aim of eliminating atrial fibrillation AF which is a common sequelae of mitral valve defects and is associated with an increased risk of ischaemic stroke heart failure and death
Detailed Description:
An open-label single-centre non-randomised study involving 16 patients male and female to evaluate the safety and efficacy of the CoolCryo system
The procedure with the medical device will be performed on female and males aged 18 years qualified for mitral heart valve surgery with a documented comorbidity of paroxysmal or persistent atrial fibrillation AF since at least 3 months prior to surgery excluding acute conditions
The study involves endocardial cryoablation of the left andor right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery with the aim of eliminating atrial fibrillation AF which is a common sequelae of mitral valve defects and is associated with an increased risk of ischaemic stroke heart failure and death
Data to assess the safety and efficacy of the CoolCryo system are collected at the time of the procedure and during the 6-month follow-up of the patient In the clinical trial of the CoolCryo system patient management at the Centre is conducted in accordance with the guidelines and standards of Polish and European medical societies as well as taking into account the best practices developed at the Centre
Due to the nature of the study population 14 patients were taken as the minimum group size for which the CoolCryo device will be used This size appears sufficient to analyse the safety and efficacy of the medical device used and was chosen for practical reasons and not on the basis of a formal sample size estimate Given the 6-month follow-up period the proportion of patients who will be lost to follow-up during the study was assumed to be 10 Therefore 16 patients will be treated
The procedure with the medical device will be performed on female and males aged 18 years qualified for mitral heart valve surgery with a documented comorbidity of paroxysmal or persistent atrial fibrillation AF since at least 3 months prior to surgery excluding acute conditions
The study involves endocardial cryoablation of the left andor right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery with the aim of eliminating atrial fibrillation AF which is a common sequelae of mitral valve defects and is associated with an increased risk of ischaemic stroke heart failure and death
Data to assess the safety and efficacy of the CoolCryo system are collected at the time of the procedure and during the 6-month follow-up of the patient In the clinical trial of the CoolCryo system patient management at the Centre is conducted in accordance with the guidelines and standards of Polish and European medical societies as well as taking into account the best practices developed at the Centre
Due to the nature of the study population 14 patients were taken as the minimum group size for which the CoolCryo device will be used This size appears sufficient to analyse the safety and efficacy of the medical device used and was chosen for practical reasons and not on the basis of a formal sample size estimate Given the 6-month follow-up period the proportion of patients who will be lost to follow-up during the study was assumed to be 10 Therefore 16 patients will be treated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None