Clinical trial NCT02166723: Persistent Atrial Fibrillation Cryoballoon Ablation
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation
Cryoballoon ablation
Lead sponsor: Staten Island University Hospital
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Time to Recurrence of atrial fibrillation
timeFrame: within 1 year after the procedure
Secondary outcomes:
measure: Procedural time
timeFrame: 1 year
Other outcomes:
Locations:
city: New york
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Marcin Kowalski, MD
role: STUDY_DIRECTOR
affiliation: Staten Island University Hospital
name: Estelle Torbey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Staten Island University Hospital
name: Soad Bekheit, MD
role: STUDY_CHAIR
References:
citation: 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.
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.