Ventricular Arrhythmias After Pulmonary Vein Isolation

Completed

• Conditions: Atrial Fibrillation; Ventricular Arrhythmias

• Registration Number: NCT02699255
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.

Detailed Description

Atrial fibrillation is the most common arrhythmia with a lifetime risk for development of over 20%. Pulmonary vein isolation is now established as therapy of choice for patients with symptomatic atrial fibrillation. It is well known that this interventional therapy inevitably modulates the intracardiac autonomic nervous system. While this ablation might alter atrial electrophysiology beneficially, the impact on ventricular electrophysiology remains unclear.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-04
• Primary Completion: 2017-01-27
• Study Completion: 2017-01-27
• Status Verified: 2018-10
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Age > 18 years
• Paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation

Exclusion Criteria

• Age < 18 years
• Persistent atrial fibrillation
• Life expectancy less than 12 months
• Acute myocardial infarction, coronary artery bypass graft surgery, open heart surgery, or percutaneous transluminal coronary angioplasty within less than 3 months prior to inclusion
• Documentation of >30 premature ventricular complexes per hour, salvos or ventricular tachycardias prior to atrial fibrillation ablation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventricular arrhythmias	one year	Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.

Secondary Outcome Measures

Name	Time	Method
Arrhythmia recurrence	one year	Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.

Trial Locations

Locations (1)

Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany