Ventricular TachycardiaMANAGE-VTNCT06455488
MANAGE-VT Registry - MANAGEment of Ventricular Tachycardia Outcomes Registry
An observational study of Ventricular Tachycardia, run by CorVita Science Foundation at 1 site in United States.
Trial summary
Data collection registry for patients with ventricular tachycardia to help physicians give better care for patients clinically and procedurally. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Ventricular Tachycardia Ablation, ICD Implant and Antiarrhythmic drug
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2020to 20 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who have been diagnosed and have evidence of ventricular tachycardia and are over the age of 18. Every patient was presented with a consent form and was given a description of the study in a clinical setting.
Who may be able to join
- Must be at least 18 years old
- Must not be
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corvita Science Foundation
Chicago, Illinois, 60643
Martin C Burke, DO, 773-520-8322, mburke@corvitahealth.org
Edward M Burke, 7737297956, eddie@corvitahealth.org
About this study
Official title: MANAGEment of Ventricular Tachycardia Outcomes Registry
Data collection registry for patients with ventricular tachycardia to help physicians give better care for patients clinically and procedurally.
Read the detailed description
After consent from a patient the research team will input patients data from many different categories. There is a link to the PDF for the consent form, a patients anticoagulant medications will be assessed, their ventricular tachycardia (VT) history will be inputted, and their date of birth and zip code will inputted. The research team will then input any EKG's, echocardiograms, VT ablations, ICD's, S-ICD's, lab results, and comorbidities.
- Conditions
- Ventricular Tachycardia
- Being tested
- Ventricular Tachycardia Ablation, ICD Implant, Antiarrhythmic drug, EKG, Cardioversion
- Keywords
- ventricular arrhythmia, ventricular tachycardia, ventricular fibrillation, stroke
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricular Tachycardia AblationProcedure or surgery
This is a surgical ablation meant to reset patients irregular rhythm back to sinus.
ICD ImplantDevice
Also called Pacemaker Implant
A pacemaker or defibrillator implant to prevent SCD
Antiarrhythmic drugDrug
Also called Statin Therapy, Anticoagulants
Drug therapies
EKGDiagnostic test
Monitoring EKG testing done on registry patients
CardioversionDiagnostic test
Monitoring cardioversions on registry patients
EchocardiogramDiagnostic test
Monitoring echocardiogram testing done on patients
| Study group | Role | What they receive |
|---|---|---|
| MANAGE-VT Patients | Patients will be assessed on the status of their ventricular tachycardia as well as other criteria such as: EKG, Receives: Procedure: Ventricular Tachycardia Ablation; Device: ICD Implant; Drug: Antiarrhythmic drug; Diagnostic Test: EKG; Diagnostic Test: Cardioversion; Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Ventricular Tachycardia
The natural progression of v-tach will be assessed through medical record review
Measured: July 20, 2020 - Present
Number of Participants with Risk of Sudden Cardiac Death
All events of sudden cardiac death that arise from patients with ventricular tachycardia
Measured: July 20, 2020 - Present
Prevent Risk of Stroke
All strokes, transient ischemic and systemic thrombo-embolic events
Measured: July 20, 2020 - Present
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start20 Jul 2020
- Primary completion20 Jul 2030 (estimated)
- Study completion20 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorVita Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455488
- Sponsor's protocol ID
- 2020-CSF-00300
- Acronym
- MANAGE-VT
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANAGEment of Ventricular Tachycardia Outcomes Registry
- ClinicalTrials.gov ID
- NCT06455488
- Acronym / sponsor ID
- MANAGE-VT / 2020-CSF-00300
- Conditions
- Ventricular Tachycardia
- Keywords
- ventricular arrhythmia, ventricular tachycardia, ventricular fibrillation, stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- CorVita Science FoundationUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Jul 2030 (estimated)
- Study completion
- 20 Jul 2030 (estimated)
- First posted
- 12 Jun 2024 (actual)
- 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.
Data collection registry for patients with ventricular tachycardia to help physicians give better care for patients clinically and procedurally.
Detailed description
After consent from a patient the research team will input patients data from many different categories. There is a link to the PDF for the consent form, a patients anticoagulant medications will be assessed, their ventricular tachycardia (VT) history will be inputted, and their date of birth and zip code will inputted. The research team will then input any EKG's, echocardiograms, VT ablations, ICD's, S-ICD's, lab results, and comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MANAGE-VT Patients | – | Procedure: Ventricular Tachycardia Ablation, Device: ICD Implant, Drug: Antiarrhythmic drug, Diagnostic Test: EKG, Diagnostic Test: Cardioversion, Diagnostic Test: EchocardiogramPatients will be assessed on the status of their ventricular tachycardia as well as other criteria such as: EKG, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have been diagnosed and have evidence of ventricular tachycardia and are over the age of 18. Every patient was presented with a consent form and was given a description of the study in a clinical setting.
Key inclusion criteria (2 listed)
- Must be at least 18 years old
- Must not be
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventricular Tachycardia AblationThis is a surgical ablation meant to reset patients irregular rhythm back to sinus. | Procedure or surgery | MANAGE-VT Patients |
| ICD ImplantAlso: Pacemaker ImplantA pacemaker or defibrillator implant to prevent SCD | Device | MANAGE-VT Patients |
| Antiarrhythmic drugAlso: Statin Therapy, AnticoagulantsDrug therapies | Drug | MANAGE-VT Patients |
| EKGMonitoring EKG testing done on registry patients | Diagnostic test | MANAGE-VT Patients |
| CardioversionMonitoring cardioversions on registry patients | Diagnostic test | MANAGE-VT Patients |
| EchocardiogramMonitoring echocardiogram testing done on patients | Diagnostic test | MANAGE-VT Patients |
Primary outcome
Recurrence of Ventricular Tachycardia
Time frame: July 20, 2020 - Present
The natural progression of v-tach will be assessed through medical record review
Number of Participants with Risk of Sudden Cardiac Death
Time frame: July 20, 2020 - Present
All events of sudden cardiac death that arise from patients with ventricular tachycardia
Prevent Risk of Stroke
Time frame: July 20, 2020 - Present
All strokes, transient ischemic and systemic thrombo-embolic events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
Related trials for Ventricular Tachycardia
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Assessment of Combined CCM and ICD Device in HFrEF
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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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)
Tachycardia, Ventricular
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by CorVita Science Foundation at 1 site 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: looking for participants now, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin C Burke, DO (7735208322, mburke@corvitahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Ventricular Tachycardia (time frame: July 20, 2020 - Present). The study lists 3 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 12 Jun 2024.