Ventricular Arrhythmias After Pulmonary Vein Isolation

Atrial Fibrillation Clinical Trial

Official title:

A Single-center Observational Study to Examine the Occurrence of Ventricular Arrhythmias After Pulmonary Vein Isolation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699255
• Other study ID #: WF-01/16
• Status: Completed
• Start date: October 2014
• Est. completion date: January 27, 2017

Study information

• Verified date: October 2018
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 27, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ventricular Arrhythmias

Locations

Country	Name	City	State
Germany	Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular arrhythmias	Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.	one year
Secondary	Arrhythmia recurrence	Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.	one year

External Links

•   full version
•   PubMed