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Clinical Trials/NCT05835791
NCT05835791
Recruiting
Not Applicable

Prospective Cohort for the sEcoNDary Prevention of Ventricular Tachycardia in Patients With Cardiomyopathies (END-VT) Study

Nova Scotia Health Authority3 sites in 1 country2,454 target enrollmentJanuary 12, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Tachycardia
Sponsor
Nova Scotia Health Authority
Enrollment
2454
Locations
3
Primary Endpoint
Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Ventricular tachycardia (VT) is a life-threatening cardiac rhythm disturbance which leads to sudden cardiac death (SCD), ventricular fibrillation, electrical storm, hemodynamic collapse, and syncope. VT patients with cardiomyopathy (diseased/scarred cardiac muscle) have the highest risk of SCD (<1-4%) and recurrent VTs (15-35%). Although an implantable cardiac defibrillator (ICD) is the most effective treatment option to prevent SCD, it does not eliminate it. Without VT prevention, recurrent VT and ICD shocks may increase the risk of heart failure and death.

The primary objective is to determine the optimal treatment strategy to maximize event-free survival among cardiomyopathy patients with ventricular tachycardia (VT) by the creation of a prospective, multicenter, longitudinal cohort. Also, the investigators will evaluate the epidemiology of VT, adherence to guidelines, safety, effectiveness, and cost-effectiveness of current treatment options for secondary prevention of VT in the real-world Canadian VT population.

Detailed Description

The END-VT study is a multicenter, prospective, longitudinal real-world cohort study of patients with cardiomyopathy-related VT. Patients with ischemic and non-ischemic cardiomyopathy are followed from their first VT event till at least 3 years of follow-up or death, whichever is first. Outcomes of VT events are captured by ICD remote monitoring and are adjudicated by experienced clinical investigators blinded to the center and treatments. The primary objective of END-VT is to determine the optimal treatment strategy to maximize event-free survival among cardiomyopathy patients with VT. The investigator will also assess the real-world burden of disease, treatment challenges, adherence to guidelines, sex differences, and safety, effectiveness, and cost-effectiveness of VT treatments.

Registry
clinicaltrials.gov
Start Date
January 12, 2024
End Date
April 30, 2029
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Documented sustained ventricular arrhythmia (\>30 seconds as documented by an ECG, cardiac monitor, AED, and/or intracardiac pacemaker/ICD electrograms (EGMs);
  • First (new) diagnosis of VT;
  • Presence of or plan for ICD implant during index hospitalization;
  • Diagnosis of cardiomyopathy (ie. ICM, hypertrophic, dilated, restrictive, arrhythmogenic cardiomyopathy, or other scar),
  • ICD clinic follow-up planned, and
  • Age \>18 years old

Exclusion Criteria

  • Patients with VT due to a reversible cause

Outcomes

Primary Outcomes

Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes

Time Frame: 5 years

Study Sites (3)

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