Overview

This trial is active, not recruiting.

Condition persistent atrial fibrillation
Treatments cryoballoon ablation
Sponsor Staten Island University Hospital
Start date January 2013
End date January 2014
Trial size 62 participants
Trial identifier NCT02166723, SIUH13-007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
Arm
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.
cryoballoon ablation Arctic Front cryoballoon
. The goal was to isolate all 4 veins with application of cryoballoon on the ostium of the vein. A 28 mm balloon was used with centrifugal cooling system. The maximum temperature reached was between -45 C and -60 C to optimize irreversible isolation without causing extracardiac complications. A circular catheter (Achieve) was used to map electrograms in conjunction with the NavX ENSITE 3000, St Judes . Intracardiac ultrasound was used to measure the pulmonary vein diameter, check for intraoperative complications, determine complete occlusion of the vein by the balloon and guide transeptal puncture. . In each patient the left atrium was debulked by applying cryoballoon
cryoballoon ablation Arctic Front cryoballoon
A 28 mm balloon was used with centrifugal cooling system. The maximum temperature reached was between -45 C and -60 C to optimize irreversible isolation without causing extracardiac complications. A circular catheter (Achieve) was used to map electrograms in conjunction with the NavX ENSITE 3000, St Judes . Intracardiac ultrasound was used to measure the pulmonary vein diameter, check for intraoperative complications, determine complete occlusion of the vein by the balloon and guide transeptal puncture. In each patient the left atrium was debulked by applying cryoballoon to the left and right sides of the left atrial roof and cryoablation of the left lateral ridge from within the left atrial appendage.

Primary Outcomes

Measure
Time to Recurrence of atrial fibrillation
time frame: within 1 year after the procedure

Secondary Outcomes

Measure
Procedural time
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Treatment of Long Persistent Atrial Fibrillation by Single Cryoballoon Ablation of the Pulmonary Veins, Left Atrial Roof Line and Ablation of Left Lateral Ridge From Within the Appendage
Principal investigator Estelle Torbey, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Staten Island University Hospital.