The purpose is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling..
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Demonstrate benefit of using the ECG Belt Research System on reducing left
ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant
compared to standard CRT.
Secondary outcome
To estimate the benefit of using the ECG Belt Research System on LVEF compared
to standard CRT.
2. To estimate the benefit of using the ECG Belt Research System on change in
quality of life compared to standard CRT.
3. To estimate the benefit of using the ECG Belt Research System on change in
Six-Minute Walk Test distance compared to standard CRT.
4. To estimate the benefit of using the ECG Belt Research System on the
Clinical Composite Score compared to standard CRT.
5. To characterize ECG Belt Research System-related AEs.
6. To assess the changes in LVESV from 6-9 months between subjects who have and
have not used the ECG Belt Research System at 6 months.
7. To assess the extent of ECG Belt Research System guided programming changes
across study visits.
Background summary
There are several unmet needs for patients with Heart Failure such as to reduce
device complications, improve efficiency of care, and maximize CRT response.LV
lead position is an important factor governing CRT response. Based on physician
surveys, a key unmet need for CRT implant procedures is a system/means to
determine acute response to CRT pacing during the implant procedure. Such
feedback may provide physicians the confidence that they are placing the LV
lead in a location that will decrease cardiac electrical dyssynchrony while
ensuring that all other clinical parameters are met including lead stability,
avoidance of phrenic nerve stimulation and reasonable pacing capture
thresholds. Such feedback may also be used during implant and/or follow-up to
determine the most optimal pacing parameters in case of a multipolar LV lead.
The ECG Belt Research System may provide a solution to this unmet need.
Study objective
The purpose is to compare ECG Belt Research System managed cardiac
resynchronization therapy (CRT) patients and a control CRT group with respect
to left ventricular (LV) remodeling.
.
Study design
Prospective, interventional, randomized, multi-center, investigational,
pre-market research study.
Upon screening of the baseline echo, eligible subjects will be randomized 2:1:1
to either the ECG Belt arm, control arm A, or control arm B respectively.
Intervention
Upon screening of the baseline echo, eligible subjects will be randomized 2:1:1
to either the ECG Belt arm, control arm A, or control arm B respectively. The
latter two arms are identically treated up until the 6-month follow-up and will
be called the control arm as a whole.
All subjects will undergo the ECG Belt Research System procedure per their
randomization assignment. After the 9-month visit subjects will be exited
Study burden and risks
There may be allergenic reaction, skin redness or irritation or discomfort from
the additional ECG Belt electrodes, minor pain or discomfort while attaching
and detaching multiple electrodes to the skin, and discomfort due to lying on
the ECG Belt.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
Indicated for CRT, with QRS duration >=130 ms, and planned to be implanted with
a market-released Medtronic CRT device and meets at least one of the following
criteria:
o QRS duration < 150 ms
o Prior documented Myocardial Infarction
o Non-LBBB
Exclusion criteria
Permanent/persistent AF or presenting with AF
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 |
|---|---|
| ClinicalTrials.gov | NCT03504020 |
| CCMO | NL68823.100.19 |