Ablation of Sources for Rapid Heart Rhythms (VTFIRM)
This study is currently recruiting participants.
Verified January 2013 by University of California, San Diego
Sponsor:
University of California, San Diego
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: January 15, 2013
Last verified: January 2013
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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 Time Perspective: Prospective |
| 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:
Biospecimen Retention: Samples With DNA
Detailed Description:
Blood
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (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 will receive 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.
- The 'active' group will receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM).
- The control group will receive 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 |
| 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:
- Documented ventricular tachyarrhythmias.
- Undergoing clinically indicated EP study with ablation.
Exclusion Criteria:
1. Unwillingness or inability to provide informed consent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492764
Contacts
| Contact: Sanjiv Narayan, MD, PhD | (858) 552-8585 ext 3539 | snarayan@ucsd.edu |
Locations
| United States, California | |
| University of California, San Diego Medical Center | Recruiting |
| San Diego, California, United States | |
| Contact: Sanjiv Narayan, MD, PhD 858-552-8585 ext 3539 snarayan@ucsd.edu | |
| Principal Investigator: Sanjiv Narayan, MD, PhD | |
| Veterans Affairs San Diego Medical Center | Recruiting |
| San Diego, California, United States | |
| Contact: Sanjiv Narayan, MD, PhD 858-552-8585 ext 3539 snarayan@ucsd.edu | |
| Principal Investigator: Sanjiv Narayan, MD, PhD | |
Sponsors and Collaborators
University of California, San Diego
Investigators
| Principal Investigator: | Sanjiv Narayan, MD, PhD | University of California, San Diego |
More Information
No publications provided
| 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: | January 15, 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 May 22, 2013