MANAGE-VT Registry - MANAGEment of Ventricular Tachycardia Outcomes Registry (MANAGE-VT)

June 11, 2024 updated by: CorVita Science Foundation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Must be at least 18 years old
  • Must not be

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MANAGE-VT Patients
Patients will be assessed on the status of their ventricular tachycardia as well as other criteria such as: EKG,
Procedure: Ventricular Tachycardia Ablation
This is a surgical ablation meant to reset patients irregular rhythm back to sinus.
Device: ICD Implant
A pacemaker or defibrillator implant to prevent SCD
Other Names:
  • Pacemaker Implant
Drug: Antiarrhythmic drug
Drug therapies
Other Names:
  • Statin Therapy
  • Anticoagulants
Diagnostic test: EKG
Monitoring EKG testing done on registry patients
Diagnostic test: Cardioversion
Monitoring cardioversions on registry patients
Diagnostic test: Echocardiogram
Monitoring echocardiogram testing done on patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Ventricular Tachycardia
Time Frame: July 20, 2020 - Present
The natural progression of v-tach will be assessed through medical record review
July 20, 2020 - Present
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
July 20, 2020 - Present
Prevent Risk of Stroke
Time Frame: July 20, 2020 - Present
All strokes, transient ischemic and systemic thrombo-embolic events
July 20, 2020 - Present

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorVita Science Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Estimated)

July 20, 2030

Study Completion (Estimated)

July 20, 2030

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-CSF-00300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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