Status:
UNKNOWN
Treatment Success With the CoolLoop Cryoablation System
Lead Sponsor:
afreeze GmbH
Collaborating Sponsors:
Raffeiner GmbH
Conditions:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 fibrilla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT03818724
Start Date
January 17 2019
End Date
January 1 2025
Last Update
July 21 2022
Active Locations (2)
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1
Medical University Innsbruck
Innsbruck, Tirol/Austria, Austria, 6020
2
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Germany/Rheinland-Pfalz, Germany, 56564