NCT00196157

Brief Summary

In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

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
116

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2004

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, 2004

Completed
1.1 years 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
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

Enrollment Period

3.8 years

First QC Date

September 12, 2005

Last Update Submit

May 28, 2009

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Sinus rhythm in follow-up

    Sinus rhythm in follow-up

Study Arms (2)

1

EXPERIMENTAL

linear lesions to ablate persistent atrial fibrillation

Procedure: linear anatomically oriented ablations

2

EXPERIMENTAL

focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Procedure: focal electrophysiological oriented ablations

Interventions

linear anatomically oriented ablationsPROCEDURE

linear lesions to ablate persistent atrial fibrillation

1
focal electrophysiological oriented ablationsPROCEDURE

focal electrophysiologically guided ablations to treat persistent atrial fibrillation

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 80 years
  • symptomatic persistent (\> 7 days lasting) atrial fibrillation
  • at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
  • oral anticoagulation (\> 4 weeks prior to ablation)

You may not qualify if:

  • moderate to severe valvular heart disease
  • congenital heart disease
  • LV-EF \< 35%
  • reversible cause for atrial fibrillation (e.g., hyperthyreosis)
  • prior left atrial ablation or Maze operation
  • left atrial thrombus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claus Schmitt, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Heidi Estner, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi 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, 2004

Primary Completion

May 1, 2008

Study Completion

November 1, 2008

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations

DE(1)