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Determining the Association of Chromosomal Variants With Non-PV Triggers and Ablation-outcome in AF (DECAF) (DECAF)

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ClinicalTrials.gov Identifier: NCT01751607
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

Brief Summary:
This prospective study aims to examine the association of specific genetic variants (single nucleotide polymorphisms) located on chromosome 1, 4 and 16, with presence of non-pulmonary vein triggers (NPVT) as well as ablation-outcome in AF patients

Condition or disease Phase
Atrial Fibrillation Phase 3

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Association of Chromosomal Variants With Non-PV Triggers and Ablation-outcome in AF (DECAF)
Study Start Date : December 2012
Primary Completion Date : August 2013
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
genetic variants
AFib patients with or without the genetic variants



Primary Outcome Measures :
  1. PVAI and isolation of all non-PV triggers [ Time Frame: 1 hour of the ablation procedure ]
    Isolation of pulmonary-vein antra and all extra-pulmonary vein triggers


Secondary Outcome Measures :
  1. Recurrence of arrhythmia [ Time Frame: Within 1 year of follow-up ]
    Recurrence will be defined as freedom from atrial flutter (AFL), AF or atrial tachycardia (AT) of > 30 seconds duration, in the absence of anti-arrhythmic drugs (AADs) at follow-up.


Biospecimen Retention:   Samples With DNA
Blood samples will be collected from which DNA would be extracted for SNP analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with atrial fibrillation
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. AF patients undergoing catheter ablation
  3. Able and willing to provide written informed consent

Exclusion Criteria:

  1. Previous left atrial catheter ablation or MAZE procedure
  2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

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): NCT01751607


Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Austin, Texas, United States, 78705
Texas Cardiac arrhythmia Institute, St. David's Hospital
Austin, Texas, United States
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
University of Texas at Austin
Investigators
Study Director: Andrea Natale, MD TCAI
Principal Investigator: Mitra Mohanty, MD TCAI

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01751607     History of Changes
Other Study ID Numbers: TCAI_DECAF
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Andrea Natale, Texas Cardiac Arrhythmia Research Foundation:
AF, catheter ablation, non-PV triggers, SNP

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