Treatment Success With the CoolLoop Cryoablation System

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: CoolLoop® cryoablation system

• Study Type: Observational
• Enrollment (Anticipated): 540

Contacts and Locations

• Study Contact: Name: Andreas Kaiser, PhD; Phone Number: +43 (0) 69911073109; Email: andreas.kaiser@afreeze.com
• Study Contact Backup: Name: afreeze GmbH; Phone Number: +43 (0) 512 209012; Email: clinical.research@afreeze.com

Study Locations

• Austria
  • Tirol/Austria
    • Innsbruck, Tirol/Austria, Austria, 6020
      • Recruiting
      • Medical University Innsbruck
• Germany
  • Germany/Rheinland-Pfalz
    • Neuwied, Germany/Rheinland-Pfalz, Germany, 56564
      • Not yet recruiting
      • Marienhaus Klinikum St. Elisabeth Neuwied

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients have to be planned and be suitable for an ablation procedure. The decision to treat the patients with the CoolLoop® cryoablation System has already been made in advance by the Investigator. Informed consent has to be obtained before the ablation procedure.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CoolLoop® cryoablation system; Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system	Device: CoolLoop® cryoablation system; Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: afreeze GmbH
• Collaborators: Raffeiner GmbH
• Investigators: Study Director: Andreas Kaiser, PhD, afreeze GmbH; Principal Investigator: Florian Hintringer, MD, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2019
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (ACTUAL): January 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cryoablation; Persistent Atrial Fibrillation; Cryosurgery; Paroxysmal Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: CooL-TreatS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No