Persistent Atrial Fibrillation
Conditions
Keywords
Persistent atrial fibrillation, Catheter ablation
Brief 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.
Interventions
PROCEDURERadiofrequency Ablation
Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.
PROCEDURECryoballoon 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.
Sponsors
Centro Cardiologico Monzino
Luigi Sacco University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication. 2. Patients presenting with Persistent AF with AF duration \< 2 years scheduled to undergo a PVAI procedure 3. Age range of 18 - 85 years 4. Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead. 5. Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Exclusion criteria
* Congenital heart disease, age younger than 18 years, significant valve disease, LA size \>55 mm, and severe heart failure (ejection fraction \< 30% and/or New York Heart Association class IV). * Presence of a mechanical prosthetic valve. * Secondary causes of atrial fibrillation * Documented intra-atrial thrombus or another abnormality which precludes catheter introduction. * Social factors that would preclude follow up or make compliance difficult.- * Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial tachycardia/fibrillation | 12 months | Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of AF episodes recorded. | 12 months | — |
| Length of postoperative hospital stay. | 1 month | — |
| Total procedural time. | 1 day | — |
| Fluoroscopy time | 1 day | — |
| Left atrial instrumentation time | 1 day | total time during which there are catheters in the LA |
| Hospitalizations after discharge. | 12 months | number of hospitalizations after discharge |
| Procedure-related complications | 1 week | Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal. |
| Number of AF episodes recorded. | 12 months | — |
| Long-term success | 36 months | freedom from AF/AFL/AT recurrences following the 3-month blanking period within 36-month follow-up from the date of the ablation procedure in the absence of Class I and III antiarrhythmic drug therapy. |
| Freedom from clinical or stroke-relevant AF/AFL/AT. | 12 months | Freedom from AF/AFL/AT with duration cutoff \> 1 hour |
| Freedom from persistent AF/AFL/AT (duration cutoff of 7 days) | 12 months | Freedom from AF/AFL/AT with duration cutoff \> 7 days |
| Regression from persistent to non-paroxysmal atrial fibrillation | 12 months | Patients converted into paroxysmal forms of AF. |
| Significant reduction in AF burden | 12 months | \>75% reduction from pre- to postablation and/or total postablation burden \<12% |
| Low daily AF burden | 12 months | Patients with AF burden less than 1%- 2% |
| Death from any cause | 12 months | — |
| Incidence of cerebrovascular events from the time of the operation up to 90 days. | 90 Days | — |
Countries
Italy
Contacts
Primary ContactGiovanni B Forleo, MD, PhD
Outcome results
None listed