Long Term Monitoring for Risk of Sudden Death (NCT04124237) | Clinical Trial Compass
CompletedNot Applicable
Long Term Monitoring for Risk of Sudden Death
Canada1,051 participantsStarted 2015-05-15
Plain-language summary
Risk prediction in in inherited heart rhythm conditions that may cause sudden cardiac arrest or death is difficult. Sometimes the risks may be low but the loss of life in an otherwise healthy young individual is catastrophic. Clinicians often treat to the extreme to prevent this and so often those at unknown risk for a serious cardiac event are treated with an implanted cardioverter defibrillator (ICD) to protect against sudden death even though the risk is low or unknown. ICDs them selves are not without adverse events such as needing battery replacements, mechanical complications, inappropriate shocks and body image and self esteem issues for the patient. This study will use an inject able monitor that is less invasive to monitor inherited heart rhythm patients long term to help gather long term heart rhythm data (3 years) on patients with an inherited heart rhythm that will help to detect symptoms of dangerous heart rhythms so that the appropriate care can be provided.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Inherited Heart Rhythm (IHR) patient with breakthrough symptoms on best medical care that does not warrant an ICD, or patient declines ICD:
. Asymptomatic IHR patient with extreme phenotype, does not warrant an ICD
. Double mutation carrier IAC patient (at least one definite and one probable disease causing)
. Patient with class 1 indication for ICD who declines it (patient or parent declines, example: young patient with cardiac arrest)
. High-risk Cardiac arrest survivors with preserved ejection fraction (CASPER) unexplained cardiac arrest (UCA) patients and family members, defined as 2 or more of 1) previous syncope suspected to be arrhythmic 2) exercise recovery QTc ≥455 msec 3) epinephrine 0.10 μg/kg/min Δ QT ≥30 msec 4) Valt\>0, k\>3during Holter9 5) QTVI \>95th %ile (\>-1) on Holter9.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Detection of ≥5 beats of non-sustained wide QRS complex tachycardia (i.e. likely to be VT).
Timeframe: From time of implant to time of cardiac event requiring intervention (maximum 3 years)
. High-risk patient not otherwise described above presented to an adjudication Committee with ≥75% consensus of risk.
. Willing signed informed consent form
. Ages 2 and over may participate (pediatric cases will be considered in Pediatric Centres only after the first 10 pilot cases are completed and reviewed by the DSMB Specialized pediatric procedures will be in developed by the pediatric clinicians)
Exclusion criteria
. Unable or unwilling to give informed consent
. ICD or pacemaker in place or considered preferable by the treating physician and/or patient/parent.