Trials / Completed
CompletedNCT03118518
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 225 (actual)
- Sponsor
- Medtronic Cardiac Ablation Solutions · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.
Detailed description
Subjects with paroxysmal atrial fibrillation with no history of treatment with anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein isolation using the cryoballoon catheter.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cryoablation | Pulmonary vein isolation via ablation with cryoballoon catheter |
| DRUG | Antiarrhythmic drug | Antiarrhythmic drug initiation |
Timeline
- Start date
- 2017-06-23
- Primary completion
- 2020-06-25
- Completion
- 2020-06-25
- First posted
- 2017-04-18
- Last updated
- 2025-02-13
- Results posted
- 2021-08-11
Locations
24 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03118518. Inclusion in this directory is not an endorsement.