Long Term Monitoring for Risk of Sudden Death

NCT04124237 | Completed DMC

• 1 other identifier: H15-00658
• Study Type: observational
• Target: 1,051
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  From time of implant to time of cardiac event requiring intervention (maximum 3 years)

Secondary Outcomes (4)

• Time to diagnosis

  From time of implant to time of recorded finding indicating a diagnosis (maximum 3 years)

• ICD implant rate

  From time of implant to time of preventative treatment (maximum 3 years)

• Mortality

  Time of implant until date of death (maximum 3 years)

• ICM Complication rate

  Time of implant to time of treatment for complication (maximum 3 years)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• Unable or unwilling to give informed consent
• ICD or pacemaker in place or considered preferable by the treating physician and/or patient/parent.

Sponsors & Collaborators

• University of British Columbia: lead
• Kingston Health Sciences Centre: collaborator
• Quebec Heart Institute: collaborator
• Montreal Heart Institute: collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6E1M7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples drawn: 1 X 9 ml EDTA DNA samples for bio banking will be stored long-term

MeSH Terms

Conditions

Long QT Syndrome; Arrhythmogenic Right Ventricular Dysplasia; Brugada Syndrome; Polymorphic Catecholaminergic Ventricular Tachycardia; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Genetic Diseases, Inborn; Tachycardia, Ventricular; Tachycardia; Heart Arrest; Death, Sudden; Death

Study Officials

• Andrew D Krahn, Dr.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Department of Medicine University of British Columbia, Chief of Cardiology

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: October 11, 2019
• Study Start: May 15, 2015
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)