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

Conditions: Cardiac Arrhythmia
10007521

Registration Number: NL-OMON32998

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 300

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

Congenital heart disease
Instable Medical condition

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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