Persistent Atrial Fibrillation Cryoballoon Ablation (PAFCA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Cryoballoon Ablation; Device: cryoballoon ablation

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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • New York
    • New york, New York, United States, 10305
      • Staten Island University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with persistent atrial fibrillation who present to staten island university hospital. Those who are listed treatment by cryoballoon ablation at the discretion of the operating physician will be included in the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CRYOABLATION; 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.

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; Other Names: Arctic Front cryoballoon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Recurrence of atrial fibrillation	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.	within 1 year after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time	The procedure time will be plotted against the date the procedure is performed to assess the improvement in operator skill.	1 year

Collaborators and Investigators

• Sponsor: Staten Island University Hospital
• Investigators: Study Director: Marcin Kowalski, MD, Staten Island University Hospital; Principal Investigator: Estelle Torbey, MD, Staten Island University Hospital; Study Chair: Soad Bekheit, MD, Staten Island University Hospital

Publications and helpful links

General Publications

• Kowalski M, Grimes MM, Perez FJ, Kenigsberg DN, Koneru J, Kasirajan V, Wood MA, Ellenbogen KA. Histopathologic characterization of chronic radiofrequency ablation lesions for pulmonary vein isolation. J Am Coll Cardiol. 2012 Mar 6;59(10):930-8. doi: 10.1016/j.jacc.2011.09.076.
• Andrade JG, Khairy P, Guerra PG, Deyell MW, Rivard L, Macle L, Thibault B, Talajic M, Roy D, Dubuc M. Efficacy and safety of cryoballoon ablation for atrial fibrillation: a systematic review of published studies. Heart Rhythm. 2011 Sep;8(9):1444-51. doi: 10.1016/j.hrthm.2011.03.050. Epub 2011 Mar 30. No abstract available. Erratum In: Heart Rhythm. 2011 Nov;8(11):1828.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 16, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Cryoballoon ablation; persistent atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SIUH13-007