Persistent Atrial Fibrillation Cryoballoon Ablation

• Conditions: Persistent Atrial Fibrillation
• Interventions: Device: cryoballoon ablation

• Registration Number: NCT02166723
• Lead Sponsor: Staten Island University Hospital

Brief Summary

Patients with persistent irregular heartbeats also called persistent atrial fibrillation usually have a lower probability of curing their arrhythmia with ablation with heat called radiofrequency then those with paroxysmal atrial fibrillation, as previous studies have shown.

The emerging ablation with freeze(cryoablation) has not been studied for persistent atrial fibrillation but has been proven to be efficient in the paroxysmal type.

We hypothesized that persistent atrial fibrillation will have a freedom of recurrence rate of 70% after use of cryoablation at one year of follow up.

Detailed Description

This was a retrospective single center cohort study designed to assess the freedom from recurrence of atrial fibrillation in the sample of patients with long persistent atrial fibrillation.

All patients who underwent cryoballoon ablation for atrial fibrillation at Staten Island University Hospital in the period ranging from January 2010 to 2013 were included in the study.

Data was collected from the electronic medical record as well as from the physician's office records after Institutional Review Board approval of the protocol

.Data collected included demographics, comorbidities pertaining to diabetes, heart failure, coronary artery disease, stroke occurrence, medications including antiarrhythmics and anticoagulants, procedural details including time of procedure and of fluoroscopy, vein ostial size, number of veins isolated, time to first recurrence after blanking period, complications of procedure and mortality. All patient identifiers were kept in a password protected computer.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Status Verified: 2014-06
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-16
• Last Update Submitted: 2014-06-16
• Study First Posted: 2014-06-18
• Last Update Posted: 2014-06-18
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• All patients included in the registry and who have symptomatic persistent atrial fibrillation presenting to the institution who favor ablation as first line therapy instead of antiarrhythmics
• All patients with symptomatic persistent atrial fibrillation who have failed antiarrhythmic therapy.

Exclusion Criteria

• Patients refusing follow up by event monitor.
• Pregnant women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRYOABLATION	cryoballoon ablation	Cryoballoon ablation will be applied to all patients with persistent atrial fibrillation. It consists on applying the Arctic Front Cryoballoon to the pulmonary veins and freezing the antrum. In addition debulking of the atrial roof will be performed by a single application of the cryoballoon to the left and right roof, the septal wall and the lateral ridge wall.

Primary Outcome Measures

Name	Time	Method
Time to Recurrence of atrial fibrillation	within 1 year after the procedure	Recurrent atrial fibrillation is defined as re occurrence of atrial fibrillation in episode of more than 3 seconds as documented by device monitoring., loop recorder, implanted devices or event monitor. Only episodes that reoccur after the blanking period of 3 month post ablation are considered as recurrence.

Secondary Outcome Measures

Name	Time	Method
Procedural time	1 year	The procedure time will be plotted against the date the procedure is performed to assess the improvement in operator skill.

Trial Locations

Locations (1)

Staten Island University Hospital; 🇺🇸 New york, New York, United States