Ablation of Sources for Rapid Heart Rhythms (VTFIRM)

This study is currently recruiting participants.
Verified December 2013 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Sanjiv Narayan, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01492764
First received: December 13, 2011
Last updated: December 11, 2013
Last verified: December 2013

December 13, 2011
December 11, 2013
June 2011
September 2016   (final data collection date for primary outcome measure)
  • reduction in ventricular tachyarrhythmias events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Using careful clinical monitoring, we will compare the burden of VT/VF after ablation (including FIRM) to the burden preceding ablation.
  • safety of ventricular basket mapping in patients undergoing ablation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    To assess the incidence of adverse events arising from ablation using basket mapping in the ventricles. These include but are not limited to stroke, systemic thromboembolism, MI or acute coronary syndrome, groin complications, or death.
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Complete list of historical versions of study NCT01492764 on ClinicalTrials.gov Archive Site
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Ablation of Sources for Rapid Heart Rhythms
Ventricular Tachyarrhythmia Focal Impulse and Rotor Modulation Trial

This study will test the hypothesis that many human heart rhythm disorders are caused by small localized sources, where brief ablation may successfully eliminate the heart rhythm disorder.

The investigators will enroll patients with documented rapid heart rates from the bottom chambers of the heart (ventricular tachyarrhythmias).

During electrophysiological study, the investigators will map the localized sources of these heart rhythm disorders.

  1. The 'active' group will prospectively receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM).
  2. The control group will be a historical cohort who have received traditional ablation for this disorder.

All patients will be followed for up to 1 year to ensure that they have no recurrent arrhythmias.

Observational
Observational Model: Case Control
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Probability Sample

Patients with documented rapid heart rhythms involving the bottom chambers of the heart.

Ventricular Tachyarrhythmias
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  • Active Group
    This group will receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM)
  • Control Group
    This group receives traditional ablation for this disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Documented ventricular tachyarrhythmias.
  2. Undergoing clinically indicated EP study with ablation.

Exclusion Criteria:

1. Unwillingness or inability to provide informed consent.

Both
21 Years to 90 Years
No
Contact: Sanjiv Narayan, MD, PhD (858) 552-8585 ext 3539 snarayan@ucsd.edu
United States
 
NCT01492764
VTFIRM2011
No
Sanjiv Narayan, MD, PhD, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Sanjiv Narayan, MD, PhD University of California, San Diego
University of California, San Diego
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP