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The Dynamics of Human Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sanjiv Narayan, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01008722
First received: November 5, 2009
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
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
Atrial Fibrillation
Atrial Tachyarrhythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Dynamics of Human Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 98
Study Start Date: June 2009
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

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
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: 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 ( US NIH Grant/Contract Award Number )
Study First Received: November 5, 2009
Results First Received: December 12, 2016
Last Updated: December 12, 2016

Keywords provided by University of California, San Diego:
Atrial Fibrillation
Ablation

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

ClinicalTrials.gov processed this record on March 27, 2017