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The Dynamics of Human Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01008722
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.

Condition or disease
Atrial Fibrillation Atrial Tachyarrhythmia

Study Design

Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Dynamics of Human Atrial Fibrillation
Study Start Date : June 2009
Primary Completion Date : April 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Survival Free of Atrial Fibrillation [ Time Frame: 6 -12 months ]
    Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as >30 seconds.


Secondary Outcome Measures :
  1. Termination or Slowing of Atrial Fibrillation During Ablation [ Time Frame: acute ]
    Using data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be men and women of all races aged 21 to 80 years undergoing clinically indicated ablation of Atrial Fibrillation.
Criteria

Inclusion Criteria:

  • Subjects will be patients undergoing electrophysiology study and ablation for paroxysmal or persistent atrial fibrillation (AF) after having failed >or= 1 anti-arrhythmic drug.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008722


Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
VA San Diego Medical Center
San Diego, California, United States, 92161
Sponsors and Collaborators
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Sanjiv M. Narayan, MD, PhD University of California, San Diego
More Information

Publications:

Responsible Party: Sanjiv Narayan, MD, PhD, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01008722     History of Changes
Other Study ID Numbers: 684
R01HL083359 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2009    Key Record Dates
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017
Last Verified: December 2016

Keywords provided by Sanjiv Narayan, MD, PhD, University of California, San Diego:
Atrial Fibrillation
Ablation

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