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

NCT ID: NCT00605748

Last Updated: 2008-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-12-31

Brief Summary

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)

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

Conditions

Atrial Fibrillation

Keywords

catheter ablation; atrial fibrillation; pulmonary vein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Segmental PV-Isolation of the arrhythmogenic vein(s)

Group Type: ACTIVE_COMPARATOR

Segmental PV-Isolation of the arrhythmogenic vein(s)

Intervention Type: PROCEDURE

isolation of pulmonary veins for curing atrial fibrillation

2

Segmental PV-Isolation of all veins

Group Type: ACTIVE_COMPARATOR

Segmental PV-Isolation of all veins

Intervention Type: PROCEDURE

isolation of pulmonary veins for curing atrial fibrillation

Interventions

Segmental PV-Isolation of the arrhythmogenic vein(s)

isolation of pulmonary veins for curing atrial fibrillation

Intervention Type: PROCEDURE

Segmental PV-Isolation of all veins

isolation of pulmonary veins for curing atrial fibrillation

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Deutsches Herzzentrum

Principal Investigators

Isabel Deisenhofer, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Heidi L. Estner, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Heidi L. Estner, MD

Role: CONTACT

Phone: +49 89 1218

Email: estner@dhm.mhn.de

Facility Contacts

Heidi L. Estner, MD

Role: primary

References

Fichtner S, Hessling G, Ammar S, Reents T, Estner HL, Jilek C, Kathan S, Buchner M, Dillier R, Deisenhofer I. A prospective randomized study comparing isolation of the arrhythmogenic vein versus all veins in paroxysmal atrial fibrillation. Clin Cardiol. 2013 Jul;36(7):422-6. doi: 10.1002/clc.22132. Epub 2013 May 13.

Reference Type: DERIVED

PMID: 23670880 (View on PubMed)

Other Identifiers

GE IDE No. C00807

Identifier Type: -

Identifier Source: org_study_id