Treatment Success With the CoolLoop Cryoablation System
NCT03818724 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 540
Last updated 2022-07-21
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.
Conditions
- Atrial Fibrillation
- Paroxysmal Atrial Fibrillation
- Persistent Atrial Fibrillation
- Arrhythmias, Cardiac
- Cardiovascular Diseases
- Heart Diseases
Interventions
- DEVICE
-
CoolLoop® cryoablation system
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
Sponsors & Collaborators
-
Raffeiner GmbH
collaborator INDUSTRY -
afreeze GmbH
lead OTHER
Principal Investigators
-
Andreas Kaiser, PhD · afreeze GmbH
-
Florian Hintringer, MD · Medical University Innsbruck
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-17
- Primary Completion
- 2025-01-31
- Completion
- 2025-01-31
Countries
- Austria
- Germany
Study Locations
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