NCT06455488

Brief Summary

Data collection registry for patients with ventricular tachycardia to help physicians give better care for patients clinically and procedurally.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
51mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jul 2020Jul 2030

Study Start

First participant enrolled

July 20, 2020

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2030

Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

10 years

First QC Date

June 5, 2024

Last Update Submit

June 11, 2024

Conditions

Ventricular Tachycardia

Keywords

ventricular arrhythmiaventricular tachycardiaventricular fibrillationstroke

Outcome Measures

Primary Outcomes (3)

  • Recurrence of Ventricular Tachycardia

    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

    All events of sudden cardiac death that arise from patients with ventricular tachycardia

    July 20, 2020 - Present

  • Prevent Risk of Stroke

    All strokes, transient ischemic and systemic thrombo-embolic events

    July 20, 2020 - Present

Study Arms (1)

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 AblationDevice: ICD ImplantDrug: Antiarrhythmic drugDiagnostic Test: EKGDiagnostic Test: CardioversionDiagnostic Test: Echocardiogram

Interventions

Ventricular Tachycardia AblationPROCEDURE

This is a surgical ablation meant to reset patients irregular rhythm back to sinus.

MANAGE-VT Patients
ICD ImplantDEVICE

A pacemaker or defibrillator implant to prevent SCD

Also known as: Pacemaker Implant
MANAGE-VT Patients
Antiarrhythmic drugDRUG

Drug therapies

Also known as: Statin Therapy, Anticoagulants
MANAGE-VT Patients
EKGDIAGNOSTIC_TEST

Monitoring EKG testing done on registry patients

MANAGE-VT Patients
CardioversionDIAGNOSTIC_TEST

Monitoring cardioversions on registry patients

MANAGE-VT Patients
EchocardiogramDIAGNOSTIC_TEST

Monitoring echocardiogram testing done on patients

MANAGE-VT Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corvita Science Foundation

Chicago, Illinois, 60643, United States

RECRUITING

MeSH Terms

Conditions

Tachycardia, VentricularVentricular FibrillationStroke

Interventions

Defibrillators, ImplantableAnti-Arrhythmia AgentsAnticoagulantsElectrocardiographyEchocardiography

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and ImplantsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesHematologic AgentsHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisCardiac Imaging TechniquesDiagnostic ImagingUltrasonography

Central Study Contacts

Martin C Burke, DO

CONTACT

7735208322mburke@corvitahealth.org

Edward M Burke

CONTACT

7737297956eddie@corvitahealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 12, 2024

Study Start

July 20, 2020

Primary Completion (Estimated)

July 20, 2030

Study Completion (Estimated)

July 20, 2030

Last Updated

June 12, 2024

Record last verified: 2024-06

Locations

US(1)