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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05835791
Other study ID # SAPP0013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 12, 2024
Est. completion date April 30, 2029

Study information

Verified date February 2024
Source Nova Scotia Health Authority
Contact John L Sapp, MD, FRCPC
Phone 902-473-4272
Email john.sapp@nshealth.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2454
Est. completion date April 30, 2029
Est. primary completion date April 30, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Canada QEII Health Science Centre Halifax Nova Scotia

Sponsors (2)

Lead Sponsor Collaborator
Nova Scotia Health Authority Maritime Heart Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes 5 years
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