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

Ventricular Tachyarrhythmias Clinical Trial

— AVATAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492764
• Other study ID #: AVATAR
• Status: Completed
• Start date: June 2011
• Est. completion date: August 2014

Study information

• Verified date: November 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Documented ventricular tachyarrhythmias.

2. Undergoing clinically indicated EP study with ablation.

Exclusion Criteria:

1. Unwillingness or inability to provide informed consent.

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachyarrhythmias

Locations

Country	Name	City	State
United States	University of California, San Diego Medical Center	San Diego	California
United States	Veterans Affairs San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in ventricular tachyarrhythmias events	Using careful clinical monitoring, we will compare the burden of VT/VF after ablation (including FIRM) to the burden preceding ablation.	3 months
Primary	safety of ventricular basket mapping in patients undergoing ablation	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.	1 month