Long Term Monitoring for Risk of Sudden Death
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|ClinicalTrials.gov Identifier: NCT04124237|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 15, 2019
|Condition or disease|
|Inherited Cardiac Arrhythmias Long QT Syndrome Arrhythmogenic Right Ventricular Cardiomyopathy Brugada Syndrome Catecholaminergic Polymorphic Ventricular Tachycardia|
Risk stratification is challenging in latent genetically mediated sudden death syndromes, where the absolute risks are low but the loss of life is catastrophic in otherwise well young individuals. Countering this is the manifest drawbacks of liberal use of Implantable Cardioverter Defibrillator (ICDs) in this population, who may suffer harm from the limitations of ICDs with respect to repeated generator changes, lead/mechanical complications, non-target shocks and issues with body image and self esteem. This balance is struck with patients and clinicians in the inherited arrhythmia clinics daily.
The Principal Investigator has a longstanding interest in cardiac monitoring and syncope, with extensive experience with cardiac monitoring technologies. Recently published data from the study team indicates that 69% of unexplained cardiac arrest patients had suffered syncope, presyncope, chest pain or palpitations, significantly greater than the 43% incidence in their first-degree relatives8. The prevalence of syncope was 34% in those patients with subsequently diagnosed inherited causes of cardiac arrest. This suggests an excellent opportunity to detect symptomatic and asymptomatic arrhythmias in patients to risk stratify patients and direct ICD resources to patients that are likely to benefit. Coupling of recording with remote monitoring of device-detected events enables a short time from detected arrhythmia to reporting and resultant clinical decision-making (base station in the patient's home transmits any acquired data daily).
An intermediate risk population is seen regularly in the inherited arrhythmia clinic, based on a wide array of clinical features that are proven or suspected risk markers in patients who either prefer to avoid an ICD, or whose risk is insufficient to clearly warrant an ICD. The risk in these individuals is hampered by the relatively uncommon short-term risk of spontaneous arrhythmia that is detected by routine 24-48 Holter surveillance to assist as a "tie breaker", to favor more aggressive therapy with an ICD. This study will extend the monitoring period of intermediate risk patients to 3 years and enable detection of symptomatic and asymptomatic ventricular arrhythmia that would inform risk discussion with the patient and favor more aggressive therapy. The latter may involve incremental drug therapy, cardiac sympathectomy or an ICD.
Loop recorder implantation (Reveal LINQ, Medtronic, Minneapolis MN), also called an insertable cardiac monitor (ICM) has the ability to analyze the beat to beat variability of cardiac cycles on a 2 minute ECG strip and stores the tracing for visual confirmation of any cardiac events. The device also provides the patient with the ability to activate the device manually and so facilitates analysis of heart rhythm during symptomatic events.
The device is manufactured and will be provided by Medtronic Canada Ltd, 99 Hereford Street, Brampton, Ontario L6Y 0R3 +1 905-460-3800. The Medtronic Reveal LINQ is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation. The form factor of the device has changed from that similar to a USB thumb drive that requires surgical implantation to that of a paper clip that can be injected in a minimally invasive environment including office based clean rooms. This device is small leadless and is inserted under the skin, in the chest. The device can be inserted by the physician in the office, saving precious healthcare resources.
Potential Adverse Events include but are not limited to:
- Device rejection phenomena (including local tissue reaction)
- Device migration
- Erosion through the skin
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Long Term Monitoring to Detect Risk of Sudden Death in Inherited Arrhythmia Patients|
|Actual Study Start Date :||May 15, 2015|
|Estimated Primary Completion Date :||January 30, 2020|
|Estimated Study Completion Date :||December 30, 2023|
- Detection of ≥5 beats of non-sustained wide QRS complex tachycardia (i.e. likely to be VT). [ Time Frame: From time of implant to time of cardiac event requiring intervention (maximum 3 years) ]The number of irregular heart rates requiring change in treatment
- Time to diagnosis [ Time Frame: From time of implant to time of recorded finding indicating a diagnosis (maximum 3 years) ]Time to determine risk and required intervention
- ICD implant rate [ Time Frame: From time of implant to time of preventative treatment (maximum 3 years) ]How many participants will require treatment with an implanted cardioverter defibrillator
- Mortality [ Time Frame: Time of implant until date of death (maximum 3 years) ]In the event of a death the cause will be classified by the site investigator as cardiac, non cardiac, sudden and non sudden
- ICM Complication rate [ Time Frame: Time of implant to time of treatment for complication (maximum 3 years) ]Number of problems related to the device, infection, pain, premature removal
Biospecimen Retention: None Retained
Blood Samples drawn:
1 X 9 ml EDTA
DNA samples for bio banking will be stored long-term
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124237
|Contact: Karen A Gibbs, RN||6046822344 ext firstname.lastname@example.org|
|Canada, British Columbia|
|St. Paul's Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V6E1M7|
|Contact: Karen A Gibbs, RN 604-682-2344 ext 63260 email@example.com|
|Contact: Emma L Christison, BScN 604-682-2344|
|Principal Investigator:||Andrew D Krahn, Dr.||University of British Columbia|