Back to resultsCardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
catheter ablation
external electric cardioversion
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation
Eligibility Criteria
Inclusion Criteria: Age >20 years and <75 years documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ECGs or holter-ECGs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter) documented sufficient anticoagulation for at least 4 weeks before inclusion Exclusion Criteria: 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
Sites / Locations
- Deutsches Herzzentrum MuenchenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
catheter ablation to treat persistent atrial fibrillation
cardioversion and drug prophylaxis to treat persistent atrial fibrillation
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
burden of atrial fibrillation in a 7-day-holter after 6 months
significant improvement in exercise capacity (measured by spiroergometry)
decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention
improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up
Full Information
NCT ID
NCT00196209
First Posted
September 12, 2005
Last Updated
March 18, 2008
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT00196209
Brief Title
Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation
Official Title
Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications.
Comparison: External cardioversion vs. catheter ablation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
catheter ablation to treat persistent atrial fibrillation
Arm Title
2
Arm Type
Experimental
Arm Description
cardioversion and drug prophylaxis to treat persistent atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
catheter ablation to treat persistent atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
external electric cardioversion
Intervention Description
external cardioversion and drug prophylaxis to treat persistent atrial fibrillation
Primary Outcome Measure Information:
Title
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
success-rate immediately after intervention
Time Frame
success-rate immediately after intervention
Title
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)
Time Frame
2-3 months
Title
burden of atrial fibrillation in a 7-day-holter after 6 months
Time Frame
6 months
Title
significant improvement in exercise capacity (measured by spiroergometry)
Time Frame
6 months
Title
decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention
Time Frame
6 months
Title
improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >20 years and <75 years
documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ECGs or holter-ECGs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter)
documented sufficient anticoagulation for at least 4 weeks before inclusion
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi L Estner, MD
Phone
0049 89 1218 2020
Email
estner@dhm.mhn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Deisenhofer, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heidi L Estner, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi L. Estner, MD
Phone
0049 89 1218-2020
Email
estner@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Heidi L Estner, MD
12. IPD Sharing Statement
Learn more about this trial
Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation
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