The Dynamics of Human Atrial Fibrillation

December 12, 2016 updated by: Sanjiv Narayan, MD, PhD, University of California, San Diego
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

98

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

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego
      • San Diego, California, United States, 92161
        • VA San Diego Medical Center

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

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 -12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
acute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Sanjiv M. Narayan, MD, PhD, University of California, San Diego

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.

General Publications

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)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 684
  • R01HL083359 (U.S. NIH Grant/Contract)

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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