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

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ClinicalTrials.gov Identifier: NCT01492764
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Diego

Study Description
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Brief Summary:
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.

Condition or disease
Ventricular Tachyarrhythmias

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)
Actual Study Start Date : June 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with documented rapid heart rhythms involving the bottom chambers of the heart.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Unwillingness or inability to provide informed consent.

Contacts and Locations
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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): NCT01492764


Locations
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United States, California
University of California, San Diego Medical Center
San Diego, California, United States
Veterans Affairs San Diego Medical Center
San Diego, California, United States
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Sanjiv Narayan, MD, PhD University of California, San Diego
More Information
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Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT01492764    
Other Study ID Numbers: AVATAR
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Keywords provided by University of California, San Diego:
Ventricular Tachyarrhythmia
Ablation
Electrophysiology
Human
Mapping
Additional relevant MeSH terms:
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Ventricular Fibrillation
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease