NCT02166723

Persistent Atrial Fibrillation Cryoballoon Ablation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Staten Island University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Cryoballoon Ablation	. 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
DEVICE	cryoballoon ablation	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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-01-01
• Completion: 2015-04-01
• First posted: 2014-06-18
• Last updated: 2014-06-18

Locations

1 site across 1 country: United States