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Pulmonary Vein (PV) -Isolation: Arrhythmogenic Vein(s) Versus All Veins (PAVAV)
This study is currently recruiting participants.
Verified by Deutsches Herzzentrum Muenchen, August 2008
Sponsored by: Deutsches Herzzentrum Muenchen
Information provided by: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00605748
  Purpose

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

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
U.S. FDA Resources
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

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • freedom of atrial tachycardia 6 months after ablation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • freedom of symptoms due to atrial tachycardia 6 months after ablation safety [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
2: Active Comparator
Segmental PV-Isolation of all veins
Procedure: Segmental PV-Isolation of all veins
isolation of pulmonary veins for curing atrial fibrillation

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients between 18 and 80 years old with paroxysmal atrial fibrillation
  • Episodes with a maximum duration for 7 days
  • at least 4 episodes / month
  • at least one attempt with Class I or III anti-arrhythmic drugs and/or with ß-blockers without success
  • sufficient oral anticoagulation for a minimum of four weeks previous to ablation

Exclusion Criteria:

  • hyperthyroidism
  • mitral regurgitation > II°
  • intracardiac thrombi documented by transesophageal echocardiography
  • left ventricular ejection< fraction 35%,
  • history of ablation, myocardial infarction or cardiac surgery in the previous 3 months
  • history of left-atrial ablation procedure
  • contraindication for oral anticoagulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605748

Contacts
Contact: Heidi L. Estner, MD +49 89 1218 ext 2020 estner@dhm.mhn.de

Locations
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            
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Isabel Deisenhofer, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Heidi L. Estner, MD Deutsches Herzzentrum Muenchen
  More Information

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  
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:
catheter ablation
atrial fibrillation
pulmonary vein

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009