Timing of Direct Current Cardioversion (DCC) in Patients Undergoing Ablation of Persistent/Permanent Atrial Fibrillation

Timing of DCC in Patients Undergoing Pulmonary Vein Isolation Ablation (PVI) of Persistent/Permanent Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: DCC first then PVI; Procedure: PVI then DCC after

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PVI performed in Normal Sinus Rhythm; DCC first then PVI	Procedure: DCC first then PVI; DCC performed prior to PVI
Active Comparator: PVI performed in Atrial Fibrillation; PVI then DCC after if patient remains in Atrial Fibrillation	Procedure: PVI then DCC after; DCC performed after PVI, if patient remains in Atrial Fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of procedure	day of procedure

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Walid Saliba, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Helpful Links

• Manuscript

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: AF
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 09-308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No