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The Vanderbilt Atrial Fibrillation Ablation Registry (VAFAR)

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: NCT02404415
Recruitment Status : Suspended
First Posted : March 31, 2015
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
M. Benjamin Shoemaker, Vanderbilt University

Brief Summary:
The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and genetic biorepository that systematically enrolls patients undergoing atrial fibrillation (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical, genetic, and serological predictors of response to AF ablation in order to improve patient selection, and 2) to provide a resource for translational research investigating the electrophysiologic mechanisms of AF pathogenesis.

Condition or disease
Atrial Fibrillation

Detailed Description:
The study population consists of patients at least 18 years of age who are scheduled for AF ablation at Vanderbilt University. Data recorded at enrollment includes a detailed past medical history and measurements from pre-ablation imaging (cardiac MRI or CT). At the time of ablation, a blood sample is collected for storage of plasma/serum and extraction of DNA, and details of the ablation procedure are recorded. Post-ablation monitoring for arrhythmia recurrence is performed according to a standard clinical follow-up schedule at 3, 6, and 12-months. ECG's are performed at each follow-up visit along with placement of an ambulatory ECG-monitor. At 6-months post-ablation, cardiac imaging with a repeat cardiac MRI or CT is performed.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The Vanderbilt Atrial Fibrillation Ablation Registry
Study Start Date : October 2011
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Atrial fibrillation recurrence [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults scheduled to undergo an atrial fibrillation ablation
Criteria

Inclusion criteria:

  1. Age >18 years
  2. Able to give written, informed consent
  3. Scheduled for an ablation procedure to treat atrial fibrillation

Exclusion criteria:

1. None


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): NCT02404415


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Moore B Shoemaker, MD, MSCI Vanderbilt University
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M. Benjamin Shoemaker, Clinical Instructor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02404415    
Other Study ID Numbers: 110881
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Keywords provided by M. Benjamin Shoemaker, Vanderbilt University:
catheter ablation
genomics
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes