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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Segmental PV-Isolation of the arrhythmogenic vein(s)
* Procedure: Segmental PV-Isolation of all veins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Segmental PV-Isolation of the arrhythmogenic vein(s) | Procedure: Segmental PV-Isolation of the arrhythmogenic vein(s)<br>* isolation of pulmonary veins for curing atrial fibrillation<br>|
| Active Comparator: 2<br>Segmental PV-Isolation of all veins | Procedure: Segmental PV-Isolation of all veins<br>* isolation of pulmonary veins for curing atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation, atrial fibrillation, pulmonary vein