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Completed

NCT Number: NCT01492764

Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)

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.

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Key information

Conditions

Ventricular Tachyarrhythmias Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Diego Medical Center, San Diego, California, United States

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About this study

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.

  • The 'active' group will prospectively receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented ventricular tachyarrhythmias.
  • Undergoing clinically indicated EP study with ablation.

Exclusion criteria

  • Unwillingness or inability to provide informed consent.

Treatment and study plan

Primary outcomes

  1. reduction in ventricular tachyarrhythmias events

    Time frame: 3 months

    Using careful clinical monitoring, we will compare the burden of VT/VF after ablation (including FIRM) to the burden preceding ablation.

  2. safety of ventricular basket mapping in patients undergoing ablation

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: AVATAR

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2011
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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