NCT01492764

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

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

June 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

3.2 years

First QC Date

December 13, 2011

Last Update Submit

November 14, 2019

Conditions

Ventricular Tachyarrhythmias

Keywords

Ventricular TachyarrhythmiaAblationElectrophysiologyHumanMapping

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \. Unwillingness or inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Diego Medical Center

San Diego, California, United States

Location

Veterans Affairs San Diego Medical Center

San Diego, California, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sanjiv Narayan, MD, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 18, 2019

Record last verified: 2019-11

Locations

US(2)