Status:
UNKNOWN
REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
Lead Sponsor:
Semmelweis University Heart and Vascular Center
Conditions:
Heart Failure
Eligibility:
All Genders
18-100 years
Brief Summary
However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial f...
Eligibility Criteria
Inclusion
- CRT-P/CRT-D patients with a feasible device for home monitoring
- ICD (VVI/VDD/DDD) patients with a feasible device for home monitoring
- SR/AFib
- Transmission performance \>80% in the first 2 weeks with new device
- Informed consent
Exclusion
- Life expectancy\<1 year
- Unable to transmit data
- Patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts
- Expected non-compliance
- Pregnancy
- Known drug, alcohol abuse
- Participation in other study or HM system concept
Key Trial Info
Start Date :
January 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06173089
Start Date
January 30 2023
End Date
August 30 2025
Last Update
December 15 2023
Active Locations (1)
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1
Semmelweis University - Heart and Vascular Center
Budapest, Hungary, 1122