NCT00408200

Brief Summary

The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2006

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

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

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

March 7, 2013

Completed
Last Updated

March 7, 2013

Status Verified

June 1, 2012

Enrollment Period

1.4 years

First QC Date

December 1, 2006

Results QC Date

September 12, 2012

Last Update Submit

January 31, 2013

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationAtrial arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug

    6 weeks

Secondary Outcomes (1)

  • Freedom From Atrial Arrhythmia at 6 Months Post Procedure.

    6 weeks

Study Arms (2)

AAD:YES

OTHER

Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.

Drug: propafenone; flecainide; sotalol; dofetilideDevice: Radiofrequency catheter ablation

AAD:NO

OTHER

Subjects do not receive membrane-active anti-arrhythmic medications after ablation.

Device: Radiofrequency catheter ablation

Interventions

propafenone; flecainide; sotalol; dofetilideDRUG

Above drugs prescribed per established guidelines for treatment of AF

AAD:YES
Radiofrequency catheter ablationDEVICE

A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.

AAD:NOAAD:YES

Eligibility Criteria

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

You may qualify if:

  • Adult patients meeting ACC/AHA criteria for paroxysmal atrial fibrillation (episodes typically last no more than 7 days and are self-terminating)
  • Eligible for pulmonary vein isolation
  • Able to tolerate antiarrhythmic medication

You may not qualify if:

  • Age \<18
  • Persistent or permanent atrial fibrillation (episodes last \>7 days and require cardioversion)
  • Antiarrhythmic treatment for indication other than atrial fibrillation
  • Contraindication or intolerance to all antiarrhythmic medications
  • Primary physician unwilling to withhold antiarrhythmic drugs for duration of the study
  • Failure to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Roux JF, Zado E, Callans DJ, Garcia F, Lin D, Marchlinski FE, Bala R, Dixit S, Riley M, Russo AM, Hutchinson MD, Cooper J, Verdino R, Patel V, Joy PS, Gerstenfeld EP. Antiarrhythmics After Ablation of Atrial Fibrillation (5A Study). Circulation. 2009 Sep 22;120(12):1036-40. doi: 10.1161/CIRCULATIONAHA.108.839639. Epub 2009 Sep 8.

    PMID: 19738139RESULT

  • Leong-Sit P, Roux JF, Zado E, Callans DJ, Garcia F, Lin D, Marchlinski FE, Bala R, Dixit S, Riley M, Hutchinson MD, Cooper J, Russo AM, Verdino R, Gerstenfeld EP. Antiarrhythmics after ablation of atrial fibrillation (5A Study): six-month follow-up study. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):11-4. doi: 10.1161/CIRCEP.110.955393. Epub 2010 Nov 13.

    PMID: 21076158DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

PropafenoneFlecainideSotaloldofetilideCatheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsAminesRadiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Results Point of Contact

Title
Anthony Killian
Organization
University of Pennsylvania
tony.killian@uphs.upenn.edu
215-615-5299

Study Officials

  • Edward P. Gerstenfeld, MD

    University of Pennsylvania Health System - Cardiac Electrophysiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2006

First Posted

December 6, 2006

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

March 7, 2013

Results First Posted

March 7, 2013

Record last verified: 2012-06

Locations

US(2)