Treatment Success With the CoolLoop Cryoablation System

Recruiting

• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Interventions: Device: CoolLoop® cryoablation system

• Registration Number: NCT03818724
• Lead Sponsor: afreeze GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-17
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CoolLoop® cryoablation system	CoolLoop® cryoablation system	Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation	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
Total procedure time	Estimated timeframe up to 4 hours	Total procedure time defined from introduction of the sheath until removal of the sheath
CoolLoop procedure time	Estimated timeframe up to 2 hours	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
Adverse Events (AEs) of special interest	36 months follow-up period	Recording of AEs of Special interest and patient reported cardiac arrhythmias
Cumulative cryoablation time	Estimated timeframe up to 1 hour	Cumulative cryoablation time is displayed as "total freeze time" by the cryoconsole at the end of the procedure
Acute procedure success	36 months follow-up period	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
Total fluoroscopy time	Estimated time frame up to 1 hour	Total fluoroscopy time defined from introduction of the sheath until removal of the sheath
CoolLoop fluoroscopy time	Estimated timeframe up to 30 minutes	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

Trial Locations

Locations (2)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tirol/Austria, Austria

Marienhaus Klinikum St. Elisabeth Neuwied; 🇩🇪 Neuwied, Germany/Rheinland-Pfalz, Germany