- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01896570
Role of Subsequent Atrial Tachycardia in Mechanisms of Persistent AF
July 10, 2013 updated by: Thomas Rostock, Johannes Gutenberg University Mainz
The Prognostic Role of Subsequent Atrial Tachycardias Occurring After Atrial Fibrillation Termination: A Prospective Randomized Trial
In this study, the investigators aim to examine the prognostic role of subsequent Atrial Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF).
Therefore, the investigators compare patients who were randomly assigned to either undergo cardioversion after AF has been terminated to AT or further ablation until the achievement of sinus rhythm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
110
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, D-20246
- University Hospital Eppendorf, Dept. of Electrophysiology
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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 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with persistent AF
Description
Inclusion Criteria:
- persistent AF for at least 1 months,
- age > 18 years,
- refractory to drug therapy,
- no prior ablation
Exclusion Criteria:
- prior AF 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A: cardioversion at AT
after achievement of AT, pts were cardioverted
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Group B: ablation to SR
After AT has been achieved, all subsequent AT were ablated with the endpoint of procedural SR termination
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arrhythmia-free survival
Time Frame: 24 months after enrolment
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24 months after enrolment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Type of Arrhythmia recurrence
Time Frame: 24 months after enrolement
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24 months after enrolement
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to recurrence
Time Frame: after blanking period (3 months) until study end (at least 24 months)
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after blanking period (3 months) until study end (at least 24 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
June 1, 2009
Primary Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
July 6, 2013
First Submitted That Met QC Criteria
July 10, 2013
First Posted (ESTIMATE)
July 11, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
July 11, 2013
Last Update Submitted That Met QC Criteria
July 10, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ciritical endpoint HH
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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