Persistent Atrial Fibrillation Cryoballoon Ablation (PAFCA)
|ClinicalTrials.gov Identifier: NCT02166723|
Recruitment Status : Unknown
Verified June 2014 by Estelle Torbey, Staten Island University Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 18, 2014
Last Update Posted : June 18, 2014
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.
|Condition or disease||Intervention/treatment|
|Persistent Atrial Fibrillation||Device: Cryoballoon Ablation Device: cryoballoon ablation|
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 [Patient Registry]|
|Actual Enrollment :||62 participants|
|Target Follow-Up Duration:||1 Year|
|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 Start Date :||January 2013|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||April 2015|
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 Name: Arctic Front cryoballoonDevice: 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.
Other Name: Arctic Front cryoballoon
- Time to Recurrence of atrial fibrillation [ Time Frame: within 1 year after the procedure ]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.
- Procedural time [ Time Frame: 1 year ]The procedure time will be plotted against the date the procedure is performed to assess the improvement in operator skill.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166723
|United States, New York|
|Staten Island University Hospital|
|New york, New York, United States, 10305|
|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|