MISSION! REMOTE Telemonitoring of Implantable Cardioverter Defibrillators: A randomized controlled trial

MISSION! REMOTE Telemonitoring of Implantable Cardioverter Defibrillators: A randomized controlled trial - MISSION! REMOTE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32998

Enrollment

300

Registered

2009-05-27

Start date

2009-03-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Cardiac Arrhythmia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Indication for ICD or CRT-D 18 years of older Capability to use either telemonitoring system throughout 12 months (Biotronik's Home Monitoring or Medtronic's CareLink)

Exclusion criteria

Exclusion criteria: Congenital heart disease Instable Medical condition

Design outcomes

Primary

Measure	Time frame
The primary purpose of this study is to evaluate whether telemonitoring can decrease the follow-up burden for ICD/CRT-D patients and clinic. Therefore, the number of interrogations will be assessed. Secondly the feasibility of telemonitoring will be tested by assessing the number of data-transmissions, patient compliance, ease of use and satisfaction.	—

Secondary

Measure	Time frame
The first secondary objective will be to assess the value of asymptomatic events and alerts, as detected by telemonitoring. Early detection and resolution of silent events hold obvious promise in the advancement of patient care. In the second secondary objective, the potential cost benefit of telemonitoring will be assessed. Thirdly, the additional information acquired by telemonitoring will be assessed. The ICDs/CRT-Ds used in this study are equipped with several monitoring features, which are innovative but not (yet) implemented in current guidelines	—

Measure

Time frame

The first secondary objective will be to assess the value of asymptomatic events and alerts, as detected by telemonitoring. Early detection and resolution of silent events hold obvious promise in the advancement of patient care. In the second secondary objective, the potential cost benefit of telemonitoring will be assessed. Thirdly, the additional information acquired by telemonitoring will be assessed. The ICDs/CRT-Ds used in this study are equipped with several monitoring features, which are innovative but not (yet) implemented in current guidelines

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Countries

Netherlands

Outcome results