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

NCT ID: NCT02429648

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-08-31

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PVI performed in Normal Sinus Rhythm

DCC first then PVI

Group Type: ACTIVE_COMPARATOR

DCC first then PVI

Intervention Type: PROCEDURE

DCC performed prior to PVI

PVI performed in Atrial Fibrillation

PVI then DCC after if patient remains in Atrial Fibrillation

Group Type: ACTIVE_COMPARATOR

PVI then DCC after

Intervention Type: PROCEDURE

DCC performed after PVI, if patient remains in Atrial Fibrillation

Interventions

DCC first then PVI

DCC performed prior to PVI

Intervention Type: PROCEDURE

PVI then DCC after

DCC performed after PVI, if patient remains in Atrial Fibrillation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Walid Saliba

Walid Saliba, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walid Saliba, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26857909 (View on PubMed)

Related Links

http://circep.ahajournals.org/content/9/2/e003596

Manuscript

Other Identifiers

09-308

Identifier Type: -

Identifier Source: org_study_id