Reduction of ICD/CRT-D follow-up by telemonitoring in a feasible way.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The increase of indicications for ICDs/CRT-Ds has led to an expansion of
ICD/CRT-D implantations worldwide resulting in an immense follow-up burden for
the outpatient clinic. Next to this, for patients having an ICD/CRT-D means
frequent device follow-up, up to 5 times during the first year. To reduce the
follow-up burden for patient and clinic, telemonitoring systems were developed.
Until now, only one randomized controlled trial has yet been performed
demonstrating that telemonitoring is as safe as standard monitoring of
ICD/CRT-D patientes. In this randomized controlled trial the feasibility and
follow-up reduction of telemonitoring will be assessed.
Study objective
Reduction of ICD/CRT-D follow-up by telemonitoring in a feasible way.
Study design
This is a prospective, randomized controlled, two-arm study enrolling patients
with ICD/CRT-D implants.
A total of 300 patients will be enrolled in this study at the Leiden University
Medical Center (LUMC) and at implantation patients are randomized for
telemonitoring or conventional, calendar-based follow-up. After the first
randomization, the patients enrolled in the telemonitoring group will have
another randomization for telemonitoring system. In the telemonitoring group
one group will use the system of Biotronik and the other the system of
Medtronic and consequently a Biotronik ICD/CRT-D or a Medtronic ICD/CRT-D will
be implanted. In the control group, a Boston Scientific ICD/CRT-D will be
implanted
Study burden and risks
Since two out of five conventional, calendar-based ICD-interrogations at our
clinic will be replaced by telemonitoring interrogations, a potential risk is
the lesser direct contact with the patient. However, on the other side,
unnoticed technical ICD/CRT-D problems or arrhythmias will be earlier detected
by telemonitoring.
Albinusdreef 2
2300 RC Leiden
NL
Albinusdreef 2
2300 RC Leiden
NL
Listed location countries
Age
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
Design
Recruitment
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 |
|---|---|
| CCMO | NL26718.058.09 |