Cardiac arrhythmias heart rhythm disorder
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients >=18 years old and have undergone ICD or CRT-D implantation for either primary or secondary prevention less than 5 years prior to enrollment; - Are participating in a remote monitoring program at AUMC or RIGS; - Having received appropriate or inappropriate ICD therapy or ventricular arrhythmias in the last 8 years prior to enrollment.
Exclusion criteria
Exclusion criteria: Unwilling to participate; Study participants with a life expectancy of less than one year; Study participants with circumstances that prevent follow-up (emigration, change of hospital for follow-up); Study participants who are unable to wear the GENEAactiv wrist-band (e.g. allergic to the material); Clinically unstable study participants; NYHA-class IV; Study participants unable to complete a questionnaire; Does not understand the local language (Dutch or Danish); Serious physical disability (e.g. wheelchair-bound); A planned ablation for ventricular tachycardia (VT; Significant movement disorder (i.e. hemiplegia or Parkinsons disease or similar)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the occurrence of inappropriate or appropriate ICD-therapy between baseline and 12-months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to appropriate/successful ICD-therapy (shock, ATP); Cumulative incidence of ICD-therapy, both inappropriate and appropriate therapy Time to inappropriate ICD-therapy (shock); Incidence of unnecessary ICD-therapy; Change in accelerometer-derived physical activity from baseline until 12-months follow-up by activity type data related; Change in accelerometer-derived sleep behavior from baseline until 12-months follow-up for different sleep-related metrics; Number of unique AF episodes from baseline until 12-months follow-up Cumulative duration of AF during the observation period Change in device-derived (D-PA) physical activity from baseline until 12-months follow-up. Mean of autonomics (night heart rate, heart rate variability) during 12-months follow-up Mean ventricular rate during episodes of AF. Incidence of and time to hospitalization (cardiovascular events, heart failure), mortality (all-cause, arrhythmic death, cardiovascular death, unexplained) and Major adverse cardiac events (MACE); Functional change from baseline onwards per NYHA functional classification; Incidence of ICD-related complications (device infection, lead dislocation, generator-related complications); Comparison of patient-reported health-related quality of life at baseline and at 12-months follow-up between patients with ICD-therapy and patients free of ICD-therapy. | — |
Countries
Netherlands
Outcome results
None listed