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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02699255
Other study ID # WF-01/16
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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