Trials / Completed
CompletedNCT01803438
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- Medtronic Cardiac Ablation Solutions · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | cryoballoon ablation system | |
| DRUG | Antiarrhythmic Drugs | AAD therapy based on hospital clinical practice according to ESC Guidelines 2012 |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2019-10-16
- Completion
- 2020-01-20
- First posted
- 2013-03-04
- Last updated
- 2025-02-13
Locations
19 sites across 9 countries: Argentina, Australia, Belgium, Croatia, France, Germany, Italy, Netherlands, Norway
Source: ClinicalTrials.gov record NCT01803438. Inclusion in this directory is not an endorsement.