Persistent Atrial Fibrillation Cryoballoon Ablation (PAFCA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Estelle Torbey, Staten Island University Hospital
ClinicalTrials.gov Identifier:
NCT02166723
First received: June 16, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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 Intervention
Persistent Atrial Fibrillation
Device: Cryoballoon Ablation
Device: cryoballoon ablation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Staten Island University Hospital:

Primary Outcome Measures:
  • Time to Recurrence of atrial fibrillation [ Time Frame: within 1 year after the procedure ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Procedural time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The procedure time will be plotted against the date the procedure is performed to assess the improvement in operator skill.


Enrollment: 62
Study Start Date: January 2013
Estimated Study Completion Date: April 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
. 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 cryoballoon
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.
Other Name: Arctic Front cryoballoon

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02166723

Locations
United States, New York
Staten Island University Hospital
New york, New York, United States, 10305
Sponsors and Collaborators
Staten Island University Hospital
Investigators
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
  More Information

Publications:
Responsible Party: Estelle Torbey, MD, Staten Island University Hospital
ClinicalTrials.gov Identifier: NCT02166723     History of Changes
Other Study ID Numbers: SIUH13-007
Study First Received: June 16, 2014
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Staten Island University Hospital:
persistent atrial fibrillation
Cryoballoon ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014