Treatment Success With the CoolLoop Cryoablation System

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03818724
• Other study ID #: CooL-TreatS
• Status: Recruiting
• Start date: January 17, 2019
• Est. completion date: January 2025

Study information

• Verified date: July 2022
• Source: afreeze GmbH
• Contact: Andreas Kaiser, PhD
• Phone: +43 (0) 69911073109
• Email: andreas.kaiser[@]afreeze.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• CoolLoop® cryoablation system
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tirol/Austria
Germany	Marienhaus Klinikum St. Elisabeth Neuwied	Neuwied	Germany/Rheinland-Pfalz

Sponsors (2)

Lead Sponsor	Collaborator
afreeze GmbH	Raffeiner GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Total procedure time	Total procedure time defined from introduction of the sheath until removal of the sheath	Estimated timeframe up to 4 hours
Secondary	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
Secondary	Total fluoroscopy time	Total fluoroscopy time defined from introduction of the sheath until removal of the sheath	Estimated time frame up to 1 hour
Secondary	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
Secondary	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
Secondary	Adverse Events (AEs) of special interest	Recording of AEs of Special interest and patient reported cardiac arrhythmias	36 months follow-up period