Recruiting

Observational Study

Sponsor:

Nova Scotia Health Authority

Code:

NCT05835791

Conditions

Ventricular Tachycardia

Implantable Defibrillator User

ICD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05835791

Start date

Jan 12, 2024

Status verified date

Jul, 2024

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

2454 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Providence Health Care Society

Recruiting

Vancouver, British Columbia, Canada

Contacts

QEII Health Science Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H3A7

Contacts

Principal Investigator:

Amir Abdelwahab

Montreal Heart Institute,

Recruiting

Montréal, Quebec, Canada, H1T 1C8

Contacts

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Jul 16, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-07-16.