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

PV-Isolation for Paroxysmal Atrial Fibrillation: Isolation of the Arrhythmogenic Vein(s) vs. Isolation of All Veins

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)

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Segmental PV-Isolation of the arrhythmogenic vein(s); Procedure: Segmental PV-Isolation of all veins

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

• Study Type: Interventional
• Enrollment (Anticipated): 212
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80636
    • Recruiting
    • Deutsches Herzzentrum Muenchen
    • Contact: Heidi L. Estner, MD; Phone Number: 0049 89 1218-2020; Email: estner@dhm.mhn.de
    • Principal Investigator: Heidi L Estner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
freedom of atrial tachycardia 6 months after ablation	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
freedom of symptoms due to atrial tachycardia 6 months after ablation safety	6 months

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Principal Investigator: Heidi L. Estner, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: January 18, 2008
• First Submitted That Met QC Criteria: January 18, 2008
• First Posted (Estimate): January 31, 2008

Study Record Updates

• Last Update Posted (Estimate): August 27, 2008
• Last Update Submitted That Met QC Criteria: August 26, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: atrial fibrillation; catheter ablation; pulmonary vein
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: GE IDE No. C00807