Trials / Unknown
UnknownNCT03365700
Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 303 (estimated)
- Sponsor
- Luigi Sacco University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation. The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent AF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Radiofrequency Ablation | Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter. |
| PROCEDURE | Cryoballoon ablation | Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure. |
Timeline
- Start date
- 2018-02-01
- Primary completion
- 2019-03-01
- Completion
- 2020-08-01
- First posted
- 2017-12-07
- Last updated
- 2018-02-23
Locations
3 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03365700. Inclusion in this directory is not an endorsement.