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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429648
• Other study ID #: 09-308
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: February 9, 2017
• Start date: June 2009
• Est. completion date: August 2015

Study information

• Verified date: January 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• DCC first then PVI
DCC performed prior to PVI
• PVI then DCC after
DCC performed after PVI, if patient remains in Atrial Fibrillation

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of procedure		day of procedure
Secondary	Composite of duration of fluoroscopy, and radiation exposure doses		day of procedure
Secondary	Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG		12 months
Secondary	frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG		12 months

External Links

•   Manuscript