Inherited Cardiac ArrhythmiasNCT04124237
Long Term Monitoring for Risk of Sudden Death
An observational study of Inherited Cardiac Arrhythmias and Long QT Syndrome, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Inherited Cardiac Arrhythmias, Long QT Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy
- How many people
- 1,051 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2015to 30 Aug 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 years and older
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Inherited Heart Rhythm (IHR) patient with breakthrough symptoms on best medical care that does not warrant an ICD, or patient declines ICD:
- Syncope or seizure that is suspected to be arrhythmic in nature with a Brugada pattern on ECG
- Long QT syndrome (LQTS)or Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) on beta blocker
- Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) with at least 2 minor or 1 major 2010 task force criteria,
- must be more than isolated disease causing gene positive
- Asymptomatic IHR patient with extreme phenotype, does not warrant an ICD
Show all 17Show fewer
- spontaneous persistent type 1 Brugada pattern
- macroscopic T wave alternates on resting ECG, Holter monitor or exercise test (especially Long QTS)
- QTc > 500 msec in LQTS, other than LQT1
- persistent asymptomatic bidirectional couplets or non-sustained PMVT in CPVT with exercise on therapy (including beta blocker and flecainide)
- definite ARVC with some high risk feature (first degree relative with SCD, couplets or nsVT on Holter)
- 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.
- 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)
Who cannot join
- Unable or unwilling to give informed consent
- ICD or pacemaker in place or considered preferable by the treating physician and/or patient/parent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Monitoring to Detect Risk of Sudden Death in Inherited Arrhythmia Patients
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.
Read the detailed description
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
- Infection
- Erosion through the skin
- Conditions
- Inherited Cardiac Arrhythmias, Long QT Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy, Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia
- Keywords
- Inherited Heart Rhythms, Genetic Heart Conditions, Sudden Cardiac Arrest, Sudden Cardiac Death
- Medical subject headings
- Long QT Syndrome, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Polymorphic Catecholaminergic Ventricular Tachycardia, Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of ≥5 beats of non-sustained wide QRS complex tachycardia (i.e. likely to be VT).
The number of irregular heart rates requiring change in treatment
Measured: From time of implant to time of cardiac event requiring intervention (maximum 3 years)
Secondary outcomes (4)
Time to diagnosis
Time to determine risk and required intervention
Measured: From time of implant to time of recorded finding indicating a diagnosis (maximum 3 years)
ICD implant rate
How many participants will require treatment with an implanted cardioverter defibrillator
Measured: From time of implant to time of preventative treatment (maximum 3 years)
Mortality
In the event of a death the cause will be classified by the site investigator as cardiac, non cardiac, sudden and non sudden
Measured: Time of implant until date of death (maximum 3 years)
ICM Complication rate
Number of problems related to the device, infection, pain, premature removal
Measured: Time of implant to time of treatment for complication (maximum 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start15 May 2015
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 1,051 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Quebec Heart Institute, Montreal Heart Institute
- Responsible party
- Principal investigator, Andrew Krahn, University of British Columbia
- Investigators
- Andrew D Krahn, Dr., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124237
- Sponsor's protocol ID
- H15-00658
- Status last verified
- Nov 2020
- First submitted
- 29 Mar 2017
- Last updated
- 16 Nov 2020
- 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 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Monitoring to Detect Risk of Sudden Death in Inherited Arrhythmia Patients
- ClinicalTrials.gov ID
- NCT04124237
- Acronym / sponsor ID
- H15-00658
- Conditions
- Inherited Cardiac Arrhythmias, Long QT Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy, Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia
- Keywords
- Inherited Heart Rhythms, Genetic Heart Conditions, Sudden Cardiac Arrest, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Quebec Heart Institute, Montreal Heart Institute
- Study start
- 15 May 2015 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 11 Oct 2019 (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.
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.
Detailed description
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
- Infection
- Erosion through the skin
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable or unwilling to give informed consent
- ICD or pacemaker in place or considered preferable by the treating physician and/or patient/parent.
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
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
4 secondary outcomes
Time to diagnosis
Time frame: From time of implant to time of recorded finding indicating a diagnosis (maximum 3 years)
ICD implant rate
Time frame: From time of implant to time of preventative treatment (maximum 3 years)
Mortality
Time frame: Time of implant until date of death (maximum 3 years)
ICM Complication rate
Time frame: Time of implant to time of treatment for complication (maximum 3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Andrew D Krahn, Dr. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inherited Cardiac Arrhythmias and Long QT Syndrome, run by University of British Columbia at 1 site 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 17 inclusion and 2 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: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 Nov 2020.