Persistent Atrial Fibrillation Cryoballoon Ablation

Persistent Atrial Fibrillation Clinical Trial

— PAFCA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02166723
• Other study ID #: SIUH13-007
• Status: Active, not recruiting
• Phase: N/A
• First received: June 16, 2014
• Last updated: June 16, 2014
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2014
• Source: Staten Island University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: April 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Staten Island University Hospital	New york	New York

Sponsors (1)

Lead Sponsor	Collaborator
Staten Island University Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. Erratum in: Heart Rhythm. 2011 Nov;8(11):1828. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Procedural time	The procedure time will be plotted against the date the procedure is performed to assess the improvement in operator skill.	1 year	No