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The SafeHeart-project

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20961
Enrollment
400
Registered
2021-01-21
Start date
2021-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantable cardioverter defibrillator.

Interventions

None listed

Sponsors

Amsterdam University Medical Centers (AUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - ICD or CRT-D implantation for either primary or secondary prevention less than 5 years prior to enrolment; - Participation in the remote monitoring program at AUMC or RIGS; - Patients =18 years old - Having received appropriate or inappropriate ICD therapy or proof of ventricular arrhythmias in the last 8 years prior to enrolment

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation for both the development-study and feasibility-study: - 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, dropping out of the remote monitoring program); - Study participants who are unable to wear the accelerometer wrist-band (e.g. allergic to the material); - Clinically unstable study participants; - End-stage of heart failure (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 Parkinson’s disease or similar).

Design outcomes

Primary

MeasureTime frame
ICD therapy

Secondary

MeasureTime frame
Mortality, MACE, hospitalization, SVT onset, quality of life

Contacts

Public ContactMaarten Kolk

Amsterdam UMC

m.kolk@amsterdamumc.nl020 566 9111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)