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

This study is currently recruiting participants.
Verified December 2012 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01751607
First received: December 11, 2012
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Phase
Atrial Fibrillation
 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Association of Chromosomal Variants With Non-PV Triggers and Ablation-outcome in AF (DECAF)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • PVAI and isolation of all non-PV triggers [ Time Frame: 1 hour of the ablation procedure ] [ Designated as safety issue: No ]
    Isolation of pulmonary-vein antra and all extra-pulmonary vein triggers


Secondary Outcome Measures:
  • Recurrence of arrhythmia [ Time Frame: Within 1 year of follow-up ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
genetic variants
AFib patients with or without the genetic variants

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751607

Contacts
Contact: Mitra Mohanty, MD 512-544-8198 mitra.mohanty@stdavids.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. david's Medical Center Not yet recruiting
Austin, Texas, United States, 78705
Contact: Mitra Mohanty, MD         mitra.mohanty@stdavids.com    
Principal Investigator: Mitra Mohanty, MD            
Principal Investigator: Andrea Natale, MD            
Texas Cardiac arrhythmia Institute, St. David's Hospital Recruiting
Austin, Texas, United States
Contact: Mitra Mohanty, MD     512-544-8198     mitra.mohanty@stdavids.com    
Principal Investigator: Andrea Natale, MD            
Principal Investigator: Mitra Mohanty, MD            
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
  More Information

No publications provided

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
Study First Received: December 11, 2012
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013