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Sponsored by: |
Deutsches Herzzentrum Muenchen |
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Information provided by: | Deutsches Herzzentrum Muenchen |
ClinicalTrials.gov Identifier: | NCT00605748 |
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of the arrhythmogenic pulmonary vein(s)
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Procedure: Segmental PV-Isolation of the arrhythmogenic vein(s) Procedure: Segmental PV-Isolation of all veins |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | PV-Isolation for Paroxysmal Atrial Fibrillation: Isolation of the Arrhythmogenic Vein(s) vs. Isolation of All Veins |
Estimated Enrollment: | 212 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Segmental PV-Isolation of the arrhythmogenic vein(s)
|
Procedure: Segmental PV-Isolation of the arrhythmogenic vein(s)
isolation of pulmonary veins for curing atrial fibrillation
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2: Active Comparator
Segmental PV-Isolation of all veins
|
Procedure: Segmental PV-Isolation of all veins
isolation of pulmonary veins for curing atrial fibrillation
|
BACKGROUND Atrial fibrillation ablation procedures typically involve isolation of all pulmonary veins (PVs), yet the need for such an extensive ablation strategy in all patients is unclear.
OBJECTIVE:
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of only the arrhythmogenic pulmonary vein(s).
The single-blind interventional, randomized study will include 106 patients in each arm.
A reablation procedure, with the use of the same technique as the first ablation, will be offered to the patient in case of a symptomatic atrial fibrillation recurrence beyond the third month after the ablation procedure.
Follow-Up After discharge, patients w ill be scheduled for repeated visits in the arrhythmia clinic at 3 and 6 months after the first ablation. At each of these visits, intensive questioning for arrhythmia-related symptoms (fatigue, dizziness, and nausea) since the last follow-up visit was performed, especially for those that the patient had experienced before ablation. At every follow-up visit, 7-day Holter monitoring w ill be performed.
Multislice CT or MRI of the pulmonary vein w ill be obtained before and 3 months after the ablation procedure for evaluation of the pulmonary vein anatomy and for detection of radiofrequency ablation-induced pulmonary vein stenosis .
Study End Points and Definitions The primary end point of the study will be freedom from atrial tachyarrhythmias (of > 30-second duration) including atrial fibrillation and atypical atrial flutter documented by 7-day Holter monitoring performed at the 6-month follow-up. Two secondary study end points will be chosen. The first will be freedom from arrhythmia-related symptoms during the 6-month follow-up. Because early recurrences of atrial tachyarrhythmias within the first month after ablation may be a transient phenomenon, this time interval was excluded from analysis. Second, a composite of periprocedural pericardial tamponade, thromboembolic complications, and pulmonary vein stenosis with > 50% lumen loss (main vessel or first branching) was defined as a safety end point
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heidi L. Estner, MD | +49 89 1218 ext 2020 | estner@dhm.mhn.de |
Germany | |
Deutsches Herzzentrum Muenchen | Recruiting |
Munich, Germany, 80636 | |
Contact: Heidi L. Estner, MD 0049 89 1218-2020 estner@dhm.mhn.de | |
Principal Investigator: Heidi L Estner, MD |
Study Chair: | Isabel Deisenhofer, MD | Deutsches Herzzentrum Muenchen |
Principal Investigator: | Heidi L. Estner, MD | Deutsches Herzzentrum Muenchen |
Responsible Party: | Deutsches Herzzentrum ( Prof. A. Schömig ) |
Study ID Numbers: | GE IDE No. C00807 |
Study First Received: | January 18, 2008 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00605748 History of Changes |
Health Authority: | Germany: Ethics Commission |
catheter ablation atrial fibrillation pulmonary vein |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |