Treatment Success With the CoolLoop Cryoablation System

Last updated: July 20, 2022
Sponsor: afreeze GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Chest Pain

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT03818724
CooL-TreatS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withthe CoolLoop® cryoablation system
  • signed and dated informed consent documented by the patient, indicating that thepatient has been informed of all the pertinent aspects of the trial prior to studyenrollment (patient has received a copy of the ICF)

Exclusion

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 enrollmentor high-risk surgical patients.
  • pregnant women at the time of the cryoablation procedure.
  • any serious medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from signing the Informed Consent Form.
  • participation in interventional trials for cardiovascular devices or drugs.

Study Design

Total Participants: 540
Study Start date:
January 17, 2019
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • Medical University Innsbruck

    Innsbruck, Tirol/Austria 6020
    Austria

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, Baden-Württemberg 89081
    Germany

    Site Not Available

  • Marienhaus Klinikum St. Elisabeth Neuwied

    Neuwied, Germany/Rheinland-Pfalz 56564
    Germany

    Site Not Available

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