Persistent Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Catheter ablation, Cryoablation, Cryoballoon, Posterior left atrial wall ablation, Pulmonary vein isolation
Brief summary
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone. The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.
Detailed description
Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all patients will be randomized to either PVI alone or the combination of PVI + posterior left atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be completed at that time. For those patients randomized to PVI + PWI, they will have additional ablation to achieve PWI. All study patients will have the same follow-up after their ablation procedure, including clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the ablation. Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the decision of the study doctor. Information about the patients' medical history, heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed.
Interventions
PROCEDUREStandard Cryoballoon Pulmonary Vein Isolation (PVI)
Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone
DEVICECryoballoon PVI + Posterior Wall Isolation
Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component
Sponsors
Mercy General Hospital and Dignity Health Medical Foundation
Beth Israel Deaconess Medical Center
UC Health Medical Center
MedStar Georgetown University Hospital and Medical Center
Tampa Cardiac Specialists
Bethesda North Hospital
Brigham and Women's Hospital
Texas Cardiac Arrhythmia Institute At St. Davids Medical Center
St. Luke's Hospital and Health Network, Pennsylvania
Sarasota Memorial Health Care System
Nebraska Methodist Hospital-Methodist Physicians Clinic
Dignity Health Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consistent with the current definitions, all patients with Persistent AF must exhibit an episode of continuous AF that is sustained \>7 days. * Patients must have symptomatic Persistent AF refractory or intolerant to at least one class I or class III antiarrhythmic drug * Males and females with an age \>18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted * All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements * Patients must have documented episode of AF greater than 7 days in the year prior to the procedure
Exclusion criteria
* History of long-standing persistent AF * Any reversible cause of AF (post-operative, thyroid disorder, etc.) * Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months * Patients with any corrected or uncorrected congenital heart disease * Patients with a history of hypertrophic cardiomyopathy * Patients with cardiomyopathy and a left ventricular ejection fraction \<40% * Congestive heart failure, class IV * Left atrial (LA) diameter \>55 mm (parasternal long axis view) * Patients with left atrial thrombus * Women who are known to be pregnant or have had a positive β-HCG (human chorionic gonadotropin) test 7 days prior to procedure * Patients whose life expectancy is \<1 year * History of left-sided left atrial ablation (catheter or surgically-based) * Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month freedom from recurrent atrial fibrillation | 12 months | Number of participants with recurrent atrial fibrillation following catheter ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF) | During a follow-up period of 12 months | Change in CCS-SAF from baseline to 12 months |
| Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) | During a follow-up period of 12 months | Change in AFEQT from baseline to 12 months |
| Multiple procedure success | During a follow-up period of 12 months | Absence of recurrent atrial arrhythmias after one or more ablation procedure(s) |
| Relative reduction in atrial fibrillation burden | During a follow-up period of 12 months | Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation |
| All atrial arrhythmia recurrences | During a follow-up period of 12 months | Number of atrial arrhythmia recurrences after the 90-day blanking period |
| Freedom from repeat atrial fibrillation ablation | During a follow-up period of 12 months | Repeat ablation for atrial fibrillation |
| Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence | During a follow-up period of 12 months | Change in left atrial diameter (in millimeters) following ablation |
| Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence | During a follow-up period of 12 months | Change in left atrial ejection fraction (in percentage) following ablation |
| New York Heart Association Functional Class as predictor of atrial fibrillation recurrence | During a follow-up period of 12 months | Change in New York Heart Association Functional Class following ablation |
| Freedom from cardioversion for recurrent atrial arrhythmias | During a follow-up period of 12 months | Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required |
Countries
United States
Outcome results
None listed