Clinical trial NCT00605748: Pulmonary Vein (PV) -Isolation: Arrhythmogenic Vein(s) Versus All Veins
Official title: PV-Isolation for Paroxysmal Atrial Fibrillation: Isolation of the Arrhythmogenic Vein(s) vs. Isolation of All Veins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: catheter ablation
atrial fibrillation
pulmonary vein
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2008-01-31
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: freedom of atrial tachycardia 6 months after ablation
timeFrame: 6 months
Secondary outcomes:
measure: freedom of symptoms due to atrial tachycardia 6 months after ablation safety
timeFrame: 6 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Isabel Deisenhofer, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Heidi L. Estner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.