Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Ablation of Sources for Rapid Heart Rhythms (VTFIRM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by University of California, San Diego.
Recruitment status was:  Recruiting
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
  Purpose
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
Ventricular Tachyarrhythmias

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Ventricular Tachyarrhythmia Focal Impulse and Rotor Modulation Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492764

Locations
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
Principal Investigator: Sanjiv Narayan, MD, PhD University of California, San Diego
  More Information

Responsible Party: Sanjiv Narayan, MD, PhD, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01492764     History of Changes
Other Study ID Numbers: VTFIRM2011 
Study First Received: December 13, 2011
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Ventricular Tachyarrhythmia
Ablation
Electrophysiology
Human
Mapping

Additional relevant MeSH terms:
Tachycardia, Ventricular
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016