Last updated: July 20, 2022
Sponsor: afreeze GmbH
Overall Status: Active - Recruiting
Phase
N/A
Condition
Circulation Disorders
Chest Pain
Vascular Diseases
Treatment
N/AClinical Study ID
NCT03818724
CooL-TreatS
Ages > 18 All Genders
Study Summary
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
AustriaActive - Recruiting
Universitätsklinikum Ulm
Ulm, Baden-Württemberg 89081
GermanySite Not Available
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Germany/Rheinland-Pfalz 56564
GermanySite Not Available
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