Clinical trial NCT02429648: Timing of Direct Current Cardioversion (DCC) in Patients Undergoing Ablation of Persistent/Permanent Atrial Fibrillation
Official title: Timing of DCC in Patients Undergoing Pulmonary Vein Isolation Ablation (PVI) of Persistent/Permanent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: AF
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Duration of procedure
timeFrame: day of procedure
Secondary outcomes:
measure: Composite of duration of fluoroscopy, and radiation exposure doses
timeFrame: day of procedure
measure: Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG
timeFrame: 12 months
measure: frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Walid Saliba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bassiouny M, Saliba W, Hussein A, Rickard J, Diab M, Aman W, Dresing T, Callahan T 4th, Bhargava M, Martin DO, Shao M, Baranowski B, Tarakji K, Tchou PJ, Hakim A, Kanj M, Lindsay B, Wazni O. Randomized Study of Persistent Atrial Fibrillation Ablation: Ablate in Sinus Rhythm Versus Ablate Complex-Fractionated Atrial Electrograms in Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e003596. doi: 10.1161/CIRCEP.115.003596.