Trials / Completed
CompletedNCT03008811
Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation
Norwegian Randomized Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation (NO PERS-AF)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Haukeland University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.
Detailed description
The purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (Arctic Front Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.Treatment success will be evaluated by using 12-lead electrocardiography and 7-day Holter recording.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Pulmonary vein isolation with cryoballoon catheter. | Device: Arctic Front Advance™ cardiac cryoablation catheter system. |
| PROCEDURE | Pulmonary vein isolation with radiofrequency ablation. | Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical). |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2021-04-01
- Completion
- 2021-05-01
- First posted
- 2017-01-02
- Last updated
- 2021-11-12
Locations
3 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT03008811. Inclusion in this directory is not an endorsement.