Demonstrate that the remote management system (Carelink, study group) reduces the time from device detected event onset to clinicaldecision for arrhythmias, cardiovascular disease progression,and system issues compared to patients receiving only in-…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase 1.
Primary Endpoint
Mean time between event onset time and clinical decision for
each subject.
Phase 2
Secondary Endpoints
1. mean time from clinical decision for any relevant event to
the end of the event, adjudicated by the Event Adjudication
Committee.
2. QoL as measured by the MNLWHF and the EQ-5D
questionnaires on a per subject basis.
Secondary outcome
Phase 2.
Primary Endpoint: death from any cause, cardiovascular and
device-related hospitalizations (at least 48 hours stay),
calculated using a time to first event analysis.
Phase 2:
Secondary Endpoints.
1. Rate of hospitalizations on a per subject basis.
2. Number of days spent in hospital (including hospitalizations,
exams, in-office visits and ED admissions) on a per subject
basis.
3. Costs of healthcare resources (including hospitalizations,
exams, in-office visits and ED admissions) on a per subject
basis.
4. QoL as measured by the MNLWHF and the EQ-5D
questionnaires a per subject basis.
5. Proportion of patients who receive optimal medical treatment
for AF.
Background summary
Remote CRT-D follow-up (via the Carelink network) is available on the market.
The main aim of this study is to demonstrate that the remote management
strategy is superior to the standard strategy, both in terms of clinical
effectiveness and total healthcare system utilisation.
Study objective
Demonstrate that the remote management system (Carelink, study group) reduces
the time from device detected event onset to clinical
decision for arrhythmias, cardiovascular disease progression,and system issues
compared to patients receiving only in-office
care (control group).
Study design
MORE-CARE is an international, prospective, multi-center, randomized,
controlled trial.
Patients will be randomized 1:1 into 2 groups:
1) Control group
2) Study group
Up to 1721 patients will be included and followed up for 24 months (average)
Approximately 80 center in EMEA will participate in the study, and this may be
extended to other sites outside EMEA..
Intervention
EXCLUSION CRITERIA
1) Inability to fully understand the instructions relating to remote monitoring
using CareLink Network.
2) Permanent AT/AF.
3) Patient has been previously implanted with a CRT/CRT-D device.
4) Patient has medical conditions that would limit study participation.
5) Patient is less than 18 years of age.
6) Patient is enrolled in or intends to participate in another clinical trial
that
may have an impact on the study endpoints.
7) Patient meets any exclusion criteria required by local law.
8) Inability or refusal to sign a patient informed consent form.
9) Patient's life expectancy is less than one year in the opinion of the
physician
10) Patient is pregnant or breastfeeding.
Study burden and risks
There are no additional risks associated with participation in this study (the
CRT-D device and Carelink network are market-released). The results of this
study will show if heart failure treatment with Carelink is better and more
efficient than heartfailure treatment without Carelink.
Postbus 2542
6401 DA Heerlen
NL
Postbus 2542
6401 DA Heerlen
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00885677 |
| CCMO | NL30703.098.09 |