NCT02429648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 10, 2017

Status Verified

January 1, 2017

Enrollment Period

4.1 years

First QC Date

February 1, 2010

Last Update Submit

February 9, 2017

Conditions

Atrial Fibrillation

Keywords

AF

Outcome Measures

Primary Outcomes (1)

  • Duration of procedure

    day of procedure

Secondary Outcomes (3)

  • 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

Study Arms (2)

PVI performed in Normal Sinus Rhythm

ACTIVE COMPARATOR

DCC first then PVI

Procedure: DCC first then PVI

PVI performed in Atrial Fibrillation

ACTIVE COMPARATOR

PVI then DCC after if patient remains in Atrial Fibrillation

Procedure: PVI then DCC after

Interventions

DCC first then PVIPROCEDURE

DCC performed prior to PVI

PVI performed in Normal Sinus Rhythm
PVI then DCC afterPROCEDURE

DCC performed after PVI, if patient remains in Atrial Fibrillation

PVI performed in Atrial Fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • 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.

    PMID: 26857909DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Walid Saliba, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Walid Saliba, MD

Study Record Dates

First Submitted

February 1, 2010

First Posted

April 29, 2015

Study Start

June 1, 2009

Primary Completion

July 1, 2013

Study Completion

August 1, 2015

Last Updated

February 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)