Atrial Fibrillation
Conditions
Keywords
AF
Brief summary
The purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if the patient remains in atrial fibrillation.
Detailed description
Ablation of persistent/permanent Atrial Fibrillation (AF) remains a challenge. There are several strategies to improve the outcomes of persistent/permanent AF ablation. At the Cleveland Clinic one of the commonly used strategies is Direct Current Cardioversion (DCC). Depending on physician preference, patients may be ablated in atrial fibrillation then Direct current cardioverted; or Direct current cardioverted and ablated in sinus rhythm. Neither approach has been shown to be superior. As both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice. The purpose of this study is to compare which standard of care strategy is superior in patients with persistent/permanent Atrial Fibrillation undergoing ablation, direct current cardioversion prior to empirical pulmonary vein isolation; or ablation in atrial fibrillation then direct current cardioversion if the patient remains in atrial fibrillation
Interventions
PROCEDUREDCC first then PVI
DCC performed prior to PVI
PROCEDUREPVI then DCC after
DCC performed after PVI, if patient remains in Atrial Fibrillation
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persistent or long standing persistent AF resistant to anti-arrhythmic medication. Must have been present for more than 2 months * Therapeutic anticoagulation for at least three weeks prior to initiation of therapy, or TEE performed prior to the procedure * Age \>= 18 years old. (Females must be either post-menopausal \>12 months, practicing a protocol-acceptable method of birth control * Scheduled for Pulmonary Vein Isolation * Amiodarone will be stopped at least 3 months prior to procedure
Exclusion criteria
* Reversible causes of AF such as pericarditis, hyperthyroidism * Presently with Valvular Heart disease requiring surgical intervention * Presently with coronary artery disease requiring surgical intervention * Early Post-operative AF (within three months of surgery) * Previous MAZE or left atrial instrumentation * Life expectancy \<= 2 years * Social factors that would preclude follow up or make compliance difficult. * Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin * Enrollment in another investigational drug or device study * Patients with severe pulmonary disease * Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of procedure | day of procedure |
Secondary
| Measure | Time frame |
|---|---|
| Composite of duration of fluoroscopy, and radiation exposure doses | day of procedure |
| Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG | 12 months |
| frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG | 12 months |
Countries
United States
Outcome results
None listed