NCT00196209

Brief Summary

The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2005

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 19, 2008

Status Verified

March 1, 2008

Enrollment Period

3.8 years

First QC Date

September 12, 2005

Last Update Submit

March 18, 2008

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcatheter ablation

Outcome Measures

Primary Outcomes (1)

  • Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death).

    6 months

Secondary Outcomes (6)

  • success-rate immediately after intervention

    success-rate immediately after intervention

  • need for re-intervention between 2 and 3 months after initial procedure if not stable sinus rhythm at the two-months follow-up (further ablation/cardioversion)

    2-3 months

  • burden of atrial fibrillation in a 7-day-holter after 6 months

    6 months

  • significant improvement in exercise capacity (measured by spiroergometry)

    6 months

  • decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention

    6 months

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

catheter ablation to treat persistent atrial fibrillation

Procedure: catheter ablation

2

EXPERIMENTAL

cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Procedure: external electric cardioversion

Interventions

catheter ablationPROCEDURE

catheter ablation to treat persistent atrial fibrillation

1
external electric cardioversionPROCEDURE

external cardioversion and drug prophylaxis to treat persistent atrial fibrillation

2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>20 years and \<75 years

You may not qualify if:

  • Paroxysmal atrial fibrillation
  • NYHA IV (if recompensation is not possible)
  • Contraindication for warfarin
  • Disturbance of blood coagulation
  • Myocardial infarction, PTCA/stenting, bypass-operation, stroke, intracranial bleeding less than 3 months before
  • Reversible causes of atrial fibrillation (i.e. hyperthyroidism)
  • Pregnancy
  • LA-diameter \> 55mm
  • LV-function \< 30% EF
  • Aortic or mitral stenosis or regurgitation III°-IV°
  • Prosthetic valves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Isabel Deisenhofer, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Heidi L Estner, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi L Estner, MD

CONTACT

0049 89 1218 2020estner@dhm.mhn.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2005

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

March 19, 2008

Record last verified: 2008-03

Locations

DE(1)