Persistent Atrial Fibrillation Cryoballoon Ablation

NCT ID: NCT02166723

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Cryoballoon Ablation

Intervention Type: DEVICE

. 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

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Arctic Front cryoballoon; Arctic Front cryoballoon

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Staten Island University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Estelle Torbey

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcin Kowalski, MD

Role: STUDY_DIRECTOR

Staten Island University Hospital

Estelle Torbey, MD

Role: PRINCIPAL_INVESTIGATOR

Staten Island University Hospital

Soad Bekheit, MD

Role: STUDY_CHAIR

Staten Island University Hospital

Locations

Staten Island University Hospital

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21457789 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22381429 (View on PubMed)

Other Identifiers

SIUH13-007

Identifier Type: -

Identifier Source: org_study_id