NCT01751607

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

8 months

First QC Date

December 11, 2012

Last Update Submit

September 4, 2014

Conditions

Keywords

AF, catheter ablation, non-PV triggers, SNP

Outcome Measures

Primary Outcomes (1)

  • PVAI and isolation of all non-PV triggers

    Isolation of pulmonary-vein antra and all extra-pulmonary vein triggers

    1 hour of the ablation procedure

Secondary Outcomes (1)

  • Recurrence of arrhythmia

    Within 1 year of follow-up

Study Arms (1)

genetic variants

AFib patients with or without the genetic variants

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with atrial fibrillation

You may qualify if:

  • Age ≥ 18 years
  • AF patients undergoing catheter ablation
  • Able and willing to provide written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Austin, Texas, 78705, United States

Location

Texas Cardiac arrhythmia Institute, St. David's Hospital

Austin, Texas, United States

Location

Related Publications (1)

  • Mohanty S, Hall AW, Mohanty P, Prakash S, Trivedi C, Di Biase L, Santangeli P, Bai R, Burkhardt JD, Gallinghouse GJ, Horton R, Sanchez JE, Hranitzky PM, Al-Ahmad A, Iyer VR, Natale A. Novel association of polymorphic genetic variants with predictors of outcome of catheter ablation in atrial fibrillation: new directions from a prospective study (DECAF). J Interv Card Electrophysiol. 2016 Jan;45(1):7-17. doi: 10.1007/s10840-015-0069-2.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from which DNA would be extracted for SNP analysis

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea Natale, MD

    TCAI

    STUDY DIRECTOR
  • Mitra Mohanty, MD

    TCAI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Medical Director

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 18, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2014

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations