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Role of Subsequent Atrial Tachycardia in Mechanisms of Persistent AF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Rostock, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01896570
First received: July 6, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Catheter ablation of subsequent atrial tachycardia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Prognostic Role of Subsequent Atrial Tachycardias Occurring After Atrial Fibrillation Termination: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Arrhythmia-free survival [ Time Frame: 24 months after enrolment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Type of Arrhythmia recurrence [ Time Frame: 24 months after enrolement ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Time to recurrence [ Time Frame: after blanking period (3 months) until study end (at least 24 months) ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: June 2009
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Procedure: Catheter ablation of subsequent atrial tachycardia

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with persistent AF

Criteria

Inclusion Criteria:

  • persistent AF for at least 1 months,
  • age > 18 years,
  • refractory to drug therapy,
  • no prior ablation

Exclusion Criteria:

  • prior AF ablation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896570

Locations
Germany
University Hospital Eppendorf, Dept. of Electrophysiology
Hamburg, Germany, D-20246
Sponsors and Collaborators
Johannes Gutenberg University Mainz
  More Information

No publications provided by Johannes Gutenberg University Mainz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Rostock, Univ.-Prof. Dr. med., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01896570     History of Changes
Other Study ID Numbers: Ciritical endpoint HH
Study First Received: July 6, 2013
Last Updated: July 10, 2013
Health Authority: Germany: ethics committee

Keywords provided by Johannes Gutenberg University Mainz:
atrial fibrillation
catheter ablation
subsequent atrial tachycardia
mechanisms

Additional relevant MeSH terms:
Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014