Ventricular TachyarrhythmiasAVATARNCT01492764
Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)
An observational study of Ventricular Tachyarrhythmias, run by University of California, San Diego at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Ventricular Tachyarrhythmias
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with documented rapid heart rhythms involving the bottom chambers of the heart.
Who may be able to join
- Documented ventricular tachyarrhythmias.
- Undergoing clinically indicated EP study with ablation.
Who cannot join
- 1. Unwillingness or inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego Medical Center
San Diego, California
Veterans Affairs San Diego Medical Center
San Diego, California
About this study
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.
Read the 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 prospectively receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM).
- 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.
- Conditions
- Ventricular Tachyarrhythmias
- Keywords
- Ventricular Tachyarrhythmia, Ablation, Electrophysiology, Human, Mapping
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachyarrhythmiasStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjiv Narayan, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492764
- Sponsor's protocol ID
- AVATAR
- Acronym
- AVATAR
- Status last verified
- Nov 2019
- First submitted
- 13 Dec 2011
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)
- ClinicalTrials.gov ID
- NCT01492764
- Acronym / sponsor ID
- AVATAR / AVATAR
- Conditions
- Ventricular Tachyarrhythmias
- Keywords
- Ventricular Tachyarrhythmia, Ablation, Electrophysiology, Human, Mapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 prospectively receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM).
- 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
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with documented rapid heart rhythms involving the bottom chambers of the heart.
Key inclusion criteria (2 listed)
- Documented ventricular tachyarrhythmias.
- Undergoing clinically indicated EP study with ablation.
Key exclusion criteria (1 listed)
- 1. Unwillingness or inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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Genetic Markers of Cardiovascular Disease in Epilepsy
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Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
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AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjiv Narayan, MD, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachyarrhythmias, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in ventricular tachyarrhythmias events (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.