The Australian CareLink Quality and Impact of Remote Follow-Up Evaluation Study (The ACQUIRE Study); to assess time and financial burden for device follow-up in patients with a pacemaker, implantable cardioverter defibrillator or cardiac resynchronisation therapy device.
Not Applicable
Active, not recruiting
- Conditions
- Remote monitoring of implanted cardiac devices: Pacemaker, Implantable Cardioverter Defibrillator (ICD) or cardiac resynchronisation therapy (CRT) deviceCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12607000517471
- Lead Sponsor
- Medtronic Australasia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 225
Inclusion Criteria
Patient is scheduled to receive (or has a previously implanted) IPG, ICD or CRT device that is supported by the Medtronic CareLink Network.
Patient has access to a telephone line where they reside, and are willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant perform those duties.
Patient signs the study consent form and agrees to comply with all study requirements
Exclusion Criteria
Patient is enrolled in, or intends to participate in, another clinical trial that might conflict with this study.
Patient has medical conditions that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient and clinician time burden[Baseline, 3 months, 6 months and study closure];Patient and clinician financial burden[Baseline, 3 months, 6 months and study closure]
- Secondary Outcome Measures
Name Time Method Patient and Clinician Ease of Use and Acceptance of CareLink[3 months, 6 months and study closure]