Long Term Monitoring for Risk of Sudden Death

2019-10-17 11:03:42 | BioPortfolio


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.


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


Inherited Cardiac Arrhythmias


St. Paul's Hospital
British Columbia




University of British Columbia

Results (where available)

View Results


Published on BioPortfolio: 2019-10-17T11:03:42-0400

Clinical Trials [1248 Associated Clinical Trials listed on BioPortfolio]

Inherited and Non-inherited Cardiac Disease Quality of Life

A prospective, longitudinal, non-comparator, non-randomized observational cohort study to assess the quality of life in adult patients affected by inherited cardiac disease (hypertrophic c...

Diagnostic Investigation of Sudden Cardiac Event Risk

Heart failure (HF) affects 5 million Americans, with 500,000 new cases diagnosed and 250,000 deaths each year. The two major causes of morbidity and mortality in HF are pump failure and s...

Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells

The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with geneti...

China Inherited Ventricular Arrhythmias Registry

This is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant inherited ventricular arrhythmias, including Brugada syndrome(Brs)、Lo...

Hypoglycemia and Cardiac Arrhythmias in Type 1 Diabetes

The investigators hypothesise that patients with type 1 diabetes have clinically relevant, but often unrecognised, episodes of arrhythmias linked to episodes of hypoglycaemia and/or clinic...

PubMed Articles [4318 Associated PubMed Articles listed on BioPortfolio]

Cardiac arrhythmias after renal I/R depend on IL-1β.

Cardiac arrhythmias are one of the most important remote complications after kidney injury. Renal ischemia reperfusion (I/R) is a major cause of acute renal injury predisposing to several remote dysfu...

Impact of transcatheter mitral valve repair on ventricular arrhythmias.

Patients with heart failure and severe mitral regurgitation (MR) have a poor prognosis and carry an increased risk for ventricular arrhythmias. The present study evaluates the impact of transcatheter ...

High-density mapping-based ablation strategies of cardiac rhythm disorders: the RHYTHMIA™ experience at new horizons.

Comment: postpartum hormones oxytocin and prolactin cause pro-arrhythmic prolongation of cardiac repolarization in long QT syndrome type 2.

Comment: postpartum hormones oxytocin and prolactin cause pro-arrhythmic prolongation of cardiac repolarization in long QT syndrome type 2-Authors' reply.

Medical and Biotech [MESH] Definitions

Any disturbances of the normal rhythmic beating of the heart or MYOCARDIAL CONTRACTION. Cardiac arrhythmias can be classified by the abnormalities in HEART RATE, disorders of electrical impulse generation, or impulse conduction.

A group of cardiac arrhythmias in which the cardiac contractions are not initiated at the SINOATRIAL NODE. They include both atrial and ventricular premature beats, and are also known as extra or ectopic heartbeats. Their frequency is increased in heart diseases.

Tumors in any part of the heart. They include primary cardiac tumors and metastatic tumors to the heart. Their interference with normal cardiac functions can cause a wide variety of symptoms including HEART FAILURE; CARDIAC ARRHYTHMIAS; or EMBOLISM.

A cardiac depressant used in arrhythmias.

Unexpected rapid natural death due to cardiovascular collapse within one hour of initial symptoms. It is usually caused by the worsening of existing heart diseases. The sudden onset of symptoms, such as CHEST PAIN and CARDIAC ARRHYTHMIAS, particularly VENTRICULAR TACHYCARDIA, can lead to the loss of consciousness and cardiac arrest followed by biological death. (from Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 7th ed., 2005)

More From BioPortfolio on "Long Term Monitoring for Risk of Sudden Death"

Quick Search

Relevant Topics

Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Searches Linking to this Trial