Clinical trial NCT05835791: END - VT Cohort Study
Official title: Prospective Cohort for the sEcoNDary Prevention of Ventricular Tachycardia in Patients With Cardiomyopathies (END-VT) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Tachycardia
Implantable Defibrillator User
ICD
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Maritime Heart Centre
First posted: 2023-04-28
Enrollment: 2454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with newly diagnosed sustained scar-related VT who meet all of the following inclusion criteria will be eligible for enrollment

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Providence Health Care Society
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Science Centre
state: Nova Scotia
city: Montréal
country: Canada
facility: Montreal Heart Institute,
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Michelle Samuel, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: John L Sapp, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: