Persistent Atrial Fibrillation Cryoballoon Ablation

NCT02166723 | Unknown DMC

• 1 other identifier: SIUH13-007
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation; Cryoballoon ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Procedural time

  1 year

Study Arms (1)

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

Interventions

cryoballoon ablation 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

Also known as: Arctic Front cryoballoon

CRYOABLATION

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients refusing follow up by event monitor.
• Pregnant women.

Sponsors & Collaborators

• Staten Island University Hospital: lead

Study Sites (1)

Staten Island University Hospital

New York, New York, 10305, United States

Location

Related 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. No abstract available.

  PMID: 21457789 BACKGROUND

• 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.

  PMID: 22381429 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcin Kowalski, MD

  Staten Island University Hospital

  STUDY DIRECTOR

• Estelle Torbey, MD

  Staten Island University Hospital

  PRINCIPAL INVESTIGATOR

• Soad Bekheit, MD

  Staten Island University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 18, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2015
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

US (1)