Trials / Unknown
UnknownNCT03818724
Treatment Success With the CoolLoop Cryoablation System
Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 540 (estimated)
- Sponsor
- afreeze GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | CoolLoop® cryoablation system | Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System |
Timeline
- Start date
- 2019-01-17
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
- First posted
- 2019-01-28
- Last updated
- 2022-07-21
Locations
2 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT03818724. Inclusion in this directory is not an endorsement.