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END - VT Cohort Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05835791
Acronym
END VT
Enrollment
2454
Registered
2023-04-28
Start date
2024-01-12
Completion date
2029-04-30
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD, Implantable Defibrillator User, Ventricular Tachycardia

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.

Interventions

None listed

Sponsors

Maritime Heart Centre
CollaboratorOTHER
Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Documented sustained ventricular arrhythmia (\>30 seconds as documented by an ECG, cardiac monitor, AED, and/or intracardiac pacemaker/ICD electrograms (EGMs); 2. First (new) diagnosis of VT; 3. Presence of or plan for ICD implant during index hospitalization; 4. Diagnosis of cardiomyopathy (ie. ICM, hypertrophic, dilated, restrictive, arrhythmogenic cardiomyopathy, or other scar), 5. ICD clinic follow-up planned, and 6. Age \>18 years old

Exclusion criteria

1\) Patients with VT due to a reversible cause

Design outcomes

Primary

MeasureTime frame
Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes5 years

Countries

Canada

Contacts

Primary ContactJohn L Sapp, MD, FRCPC
john.sapp@nshealth.ca902-473-4272
Backup ContactSuzanne E Greeley, BSCN
suzanne.greeley@nshealth.ca902-473-2149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026