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Pulmonary Vein (PV) -Isolation: Arrhythmogenic Vein(s) Versus All Veins (PAVAV)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605748
First Posted: January 31, 2008
Last Update Posted: August 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Deutsches Herzzentrum Muenchen
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: PV-Isolation for Paroxysmal Atrial Fibrillation: Isolation of the Arrhythmogenic Vein(s) vs. Isolation of All Veins

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • freedom of atrial tachycardia 6 months after ablation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • freedom of symptoms due to atrial tachycardia 6 months after ablation safety [ Time Frame: 6 months ]

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
Active Comparator: 1
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
Active Comparator: 2
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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum
ClinicalTrials.gov Identifier: NCT00605748     History of Changes
Other Study ID Numbers: GE IDE No. C00807
First Submitted: January 18, 2008
First Posted: January 31, 2008
Last Update Posted: August 27, 2008
Last Verified: August 2008

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes