- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02699255
Ventricular Arrhythmias After Pulmonary Vein Isolation
June 6, 2019 updated by: Prof. Dr. Christian Meyer, Universitätsklinikum Hamburg-Eppendorf
A Single-center Observational Study to Examine the Occurrence of Ventricular Arrhythmias After Pulmonary Vein Isolation
The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
111
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamburg, Germany, 20246
- Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventricular arrhythmias
Time Frame: one year
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Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.
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one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arrhythmia recurrence
Time Frame: one year
|
Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christian Meyer, Prof. Dr., Department of Cardiology - Electrophysiology, University Heart Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
January 27, 2017
Study Completion (Actual)
January 27, 2017
Study Registration Dates
First Submitted
February 23, 2016
First Submitted That Met QC Criteria
February 29, 2016
First Posted (Estimate)
March 4, 2016
Study Record Updates
Last Update Posted (Actual)
June 7, 2019
Last Update Submitted That Met QC Criteria
June 6, 2019
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WF-01/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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