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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DCC first then PVI
PVI then DCC after
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring AF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PVI performed in Normal Sinus Rhythm

PVI performed in Atrial Fibrillation

Arm Description

DCC first then PVI

PVI then DCC after if patient remains in Atrial Fibrillation

Outcomes

Primary Outcome Measures

Duration of procedure

Secondary Outcome Measures

Composite of duration of fluoroscopy, and radiation exposure doses
Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG
frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG

Full Information

First Posted
February 1, 2010
Last Updated
February 9, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02429648
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
AF

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVI performed in Normal Sinus Rhythm
Arm Type
Active Comparator
Arm Description
DCC first then PVI
Arm Title
PVI performed in Atrial Fibrillation
Arm Type
Active Comparator
Arm Description
PVI then DCC after if patient remains in Atrial Fibrillation
Intervention Type
Procedure
Intervention Name(s)
DCC first then PVI
Intervention Description
DCC performed prior to PVI
Intervention Type
Procedure
Intervention Name(s)
PVI then DCC after
Intervention Description
DCC performed after PVI, if patient remains in Atrial Fibrillation
Primary Outcome Measure Information:
Title
Duration of procedure
Time Frame
day of procedure
Secondary Outcome Measure Information:
Title
Composite of duration of fluoroscopy, and radiation exposure doses
Time Frame
day of procedure
Title
Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG
Time Frame
12 months
Title
frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid Saliba, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26857909
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.
Results Reference
derived

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

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