Monitoring Resynchronization in Cardiac Patients
Completed
- Conditions
- heart failureheart rhythm disturbances10007521
- Registration Number
- NL-OMON35090
- Lead Sponsor
- Medtronic Trading NL BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients with a CRT-D indication
Patient is willing and able to use the Medtronic Carelink Network
Exclusion Criteria
- Permanent AT/AF
- CRT-D replacement patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase 1.<br /><br>Primary Endpoint<br /><br>Mean time between event onset time and clinical decision for<br /><br>each subject.<br /><br><br /><br><br /><br>Phase 2<br /><br>Secondary Endpoints<br /><br>1. mean time from clinical decision for any relevant event to<br /><br>the end of the event, adjudicated by the Event Adjudication<br /><br>Committee.<br /><br>2. QoL as measured by the MNLWHF and the EQ-5D<br /><br>questionnaires on a per subject basis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Phase 2.<br /><br>Primary Endpoint: death from any cause, cardiovascular and<br /><br>device-related hospitalizations (at least 48 hours stay),<br /><br>calculated using a time to first event analysis.<br /><br><br /><br>Phase 2:<br /><br>Secondary Endpoints.<br /><br>1. Rate of hospitalizations on a per subject basis.<br /><br>2. Number of days spent in hospital (including hospitalizations,<br /><br>exams, in-office visits and ED admissions) on a per subject<br /><br>basis.<br /><br>3. Costs of healthcare resources (including hospitalizations,<br /><br>exams, in-office visits and ED admissions) on a per subject<br /><br>basis.<br /><br>4. QoL as measured by the MNLWHF and the EQ-5D<br /><br>questionnaires a per subject basis.<br /><br>5. Proportion of patients who receive optimal medical treatment<br /><br>for AF.</p><br>