Personalized and preventive mHealth predicting life-threatening arrhythmias in cardiac patients

Recruiting

• Conditions: Cardiac arrhythmias; heart rhythm disorder; 10007521

• Registration Number: NL-OMON50154
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

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

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)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the occurrence of inappropriate or appropriate<br /><br>ICD-therapy between baseline and 12-months follow-up. </p><br>