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

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

      • Hamburg, Germany, D-20246
        • University Hospital Eppendorf, Dept. of Electrophysiology

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
Group B: ablation to SR
After AT has been achieved, all subsequent AT were ablated with the endpoint of procedural SR termination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arrhythmia-free survival
Time Frame: 24 months after enrolment
24 months after enrolment

Secondary Outcome Measures

Outcome Measure
Time Frame
Type of Arrhythmia recurrence
Time Frame: 24 months after enrolement
24 months after enrolement

Other Outcome Measures

Outcome Measure
Time Frame
Time to recurrence
Time Frame: after blanking period (3 months) until study end (at least 24 months)
after blanking period (3 months) until study end (at least 24 months)

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

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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