The SafeHeart-project
- Conditions
- Implantable cardioverter defibrillator.
- Registration Number
- NL-OMON20961
- Lead Sponsor
- Amsterdam University Medical Centers (AUMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
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
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).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ICD therapy
- Secondary Outcome Measures
Name Time Method Mortality, MACE, hospitalization, SVT onset, quality of life