Treatment Success With the CoolLoop Cryoablation System

Study Overview
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Brief Summary
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This clinical study evaluates the safety and efficacy of the treatment with the CoolLoop® cryoablation System (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of 36 months. A further aim of this study is to evaluate the average duration of procedure and fluoroscopy times.

Official Title
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Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance

Conditions
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Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases

Intervention / Treatment
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* Device: CoolLoop® cryoablation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years atrial fibrillation: permanent AF excepted ECG documented AF within the last 6 months patients planned for an ablation procedure and suitable and planned for treatment with the CoolLoop® cryoablation system signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment (patient has received a copy of the ICF) Exclusion Criteria: indication that the vascular system is not accessible through the left or right groin. indication that a transseptal puncture cannot be performed. any previous ablation or surgery due to AF. important comorbidities such as cardiovascular events within six months of enrollment or high-risk surgical patients. pregnant women at the time of the cryoablation procedure. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form. participation in interventional trials for cardiovascular devices or drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CoolLoop® cryoablation system<br>Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system | Device: CoolLoop® cryoablation system<br>* Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events | Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation | 36 months follow-up period | 
| Freedom from atrial fibrillation (efficacy) at 36 months post-ablation | Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 36 months post-ablation | 36 months follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation | Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 12 and 24 months post-ablation | 12 and 24 months post-ablation | 
| Acute procedure success | Acute efficacy of isolation of each of the pulmonary veins defined as the percentage of diagnostic mapping catheter electrode pairs within the pulmonary vein without any detectable pulmonary vein signal in case of redo procedure | 36 months follow-up period | 
| Total procedure time | Total procedure time defined from introduction of the sheath until removal of the sheath | Estimated timeframe up to 4 hours | 
| CoolLoop procedure time | CoolLoop procedure time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after Termination of the last cryo-application with the CoolLoop cryoablation catheter | Estimated timeframe up to 2 hours | 
| Total fluoroscopy time | Total fluoroscopy time defined from introduction of the sheath until removal of the sheath | Estimated time frame up to 1 hour | 
| CoolLoop fluoroscopy time | CoolLoop fluoroscopy time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after termination of the last cryo-application with the CoolLoop cryoablation catheter | Estimated timeframe up to 30 minutes | 
| Cumulative cryoablation time | Cumulative cryoablation time is displayed as total freeze time by the cryoconsole at the end of the procedure | Estimated timeframe up to 1 hour | 
| Adverse Events (AEs) of special interest | Recording of AEs of Special interest and patient reported cardiac arrhythmias | 36 months follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryosurgery