Status:
COMPLETED
Long Term Monitoring for Risk of Sudden Death
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Kingston Health Sciences Centre
Quebec Heart Institute
Conditions:
Inherited Cardiac Arrhythmias
Long QT Syndrome
Eligibility:
All Genders
2+ years
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 in...
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. Cou...
Eligibility Criteria
Inclusion
- 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.
- 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
- Unable or unwilling to give informed consent
- ICD or pacemaker in place or considered preferable by the treating physician and/or patient/parent.
Key Trial Info
Start Date :
May 15 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
1051 Patients enrolled
Trial Details
Trial ID
NCT04124237
Start Date
May 15 2015
End Date
August 30 2020
Last Update
November 16 2020
Active Locations (1)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6E1M7