END - VT Cohort Study

NCT05835791 | Recruiting DMC

• 1 other identifier: SAPP0013
• Study Type: observational
• Target: 2,454
• Locations: 1 country
• Sites: 3

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.

Conditions

Ventricular Tachycardia; Implantable Defibrillator User; ICD

Outcome Measures

Primary Outcomes (1)

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

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \) Patients with VT due to a reversible cause

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Maritime Heart Centre: collaborator

Study Sites (3)

Providence Health Care Society

Vancouver, British Columbia, Canada

RECRUITING

QEII Health Science Centre

Halifax, Nova Scotia, B3H3A7, Canada

RECRUITING

Montreal Heart Institute,

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Samuel, MPH, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• John L Sapp, MD, FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John L Sapp, MD, FRCPC

CONTACT

902-473-4272; john.sapp@nshealth.ca

Suzanne E Greeley, BSCN

CONTACT

902-473-2149; suzanne.greeley@nshealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 28, 2023
• Study Start: January 12, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)