Ventricular TachycardiaEND VTNCT05835791
END - VT Cohort Study
An observational study of Ventricular Tachycardia and Implantable Defibrillator User, run by Nova Scotia Health Authority at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Implantable Defibrillator User, ICD
- How many people
- 2,454 participants
- Where
- 3 sitesCanada
- Study dates
- 12 Jan 2024to 30 Apr 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with newly diagnosed sustained scar-related VT who meet all of the following inclusion criteria will be eligible for enrollment
Who may be able to join
- 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
Who cannot join
- 1) Patients with VT due to a reversible cause
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
QEII Health Science Centre
Halifax, Nova Scotia, B3H3A7
Suzanne Greeley, BScN, 902-473-2149, suzanne.greeley@nshealth.ca
Amir Abdelwahab
- Recruiting
Montreal Heart Institute,
Montreal, Quebec, H1T 1C8
Lena Rivard, Lena.Rivard@icm-mhi.org
- Recruiting
Providence Health Care Society
Vancouver, British Columbia
Marc Deyell, MDeyell@providencehealth.bc.ca
About this study
Official title: Prospective Cohort for the sEcoNDary Prevention of Ventricular Tachycardia in Patients With Cardiomyopathies (END-VT) Study
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.
Read the 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.
- Conditions
- Ventricular Tachycardia, Implantable Defibrillator User, ICD
- Medical subject headings
- Tachycardia, Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start12 Jan 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,454 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Maritime Heart Centre
- Responsible party
- Sponsor
- Investigators
- Michelle Samuel, MPH, PhD, Principal investigator, Montreal Heart InstituteJohn L Sapp, MD, FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835791
- Sponsor's protocol ID
- SAPP0013
- Acronym
- END VT
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort for the sEcoNDary Prevention of Ventricular Tachycardia in Patients With Cardiomyopathies (END-VT) Study
- ClinicalTrials.gov ID
- NCT05835791
- Acronym / sponsor ID
- END VT / SAPP0013
- Conditions
- Ventricular Tachycardia, Implantable Defibrillator User, ICD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,454 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Maritime Heart Centre
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with newly diagnosed sustained scar-related VT who meet all of the following inclusion criteria will be eligible for enrollment
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 1) Patients with VT due to a reversible cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Samuel, MPH, PhD principal investigator
Montreal Heart Institute
John L Sapp, MD, FRCPC principal investigator
Nova Scotia Health Authority
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Implantable Defibrillator User, run by Nova Scotia Health Authority at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John L Sapp, MD, FRCPC (902-473-4272, john.sapp@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.