We hypothesize that a noninvasive ECGI mapping-based system, like the Amycard 01C system, can provide information valuable for both selecting patients for CRT therapy, planning the CRT procedure, guiding the actual CRT lead placement during…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the LVESV, assessed by echo examination at 6-12 months post
CRT implan-tation. The cut-off parameter for response/non-response is LVESV
reduction of 15% or more versus baseline.
LV size should be assessed on a 2D echo examination by calculating volumes
using the biplane method of disks summation technique. In sites and operators
with experience in 3D echo, 3D measurement and reporting of LV volumes is
recommended when feasible depending on image quality, see further details in
the recommendations of the American Society of Echocardiog-raphy and the
European Association of Cardiovascular Imaging (#23 in the reference list).
Secondary outcome
Secondary endpoint is a composite clinical score of death and HF
hospitalization at 12 months
post-implantation.
Note:
The LVESV parameter will assess patient improvement at the 6-12 months
follow-up-visit. However, to accommodate variance in the timing of the
follow-up-visit, deaths and HF hospitalizations will be taken into account
until 12 months after the implantation.
Background summary
The use of ECGI in current electrocardiography practice aims at reconstructing
epicardial and endocardial electrical signals from the heart in order to detect
disorders in the cardiac electri-cal system. The Amycard 01C System (previously
called EPCard IVM) has been technically and clinically validated, which also
formed the basis for the acquired CE certification of the system.
The question which was the basis for validating with regard to the system
performance was the capability of the Amycard 01C System to accurately generate
epicardial and endocardial maps of the cardiac electrical activity and,
further, to detect ectopic events for their use in the diag-nostic process. The
evaluation of the performance relies on a series of 8 clinical studies carried
out with the Amycard 01C System on a total of 118 patients as well as on
clinical studies pub-lished on an equivalent device.
All studies conducted on the Amycard 01C System concur to establish the
clinical utility of the system as a tool for the non-invasive study of various
cardiac diseases that would otherwise require an invasive electrophysiological
study. Both clinical validation data and data collected from Post Market
Studies (PMS) indicate that the Amycard 01C System is safe and performant when
used with either CT or MRI imaging modalities. The studies confirm the
suitability of non-invasive mapping.
Study objective
We hypothesize that a noninvasive ECGI mapping-based system, like the Amycard
01C system, can provide information valuable for both selecting patients for
CRT therapy, planning the CRT procedure, guiding the actual CRT lead placement
during implantation as well as optimizing the CRT therapy, leading to a better
selection of patients for CRT and an overall improved outcome of the procedure
and thus reducing the current 20-50% procedure failure rate.
Based on the above hypothesis we foresee a long-term clinical roadmap that can
be divided into the following sub-studies:
1. Demonstrate that the non-invasive ECGI mapping can predict CRT response *
retrospec-tive study in patients undergone CRT implantation.
2. Demonstrate that prospective use of ECGI map to guide LV electrode placement
by as-sessing the LV Late Activation Zone (LAZ) in relation to
CT venography provides better CRT outcome (prospective randomised
controlled study).
3. Demonstrate that pre-procedure assessment of the LAZ vs CT venogram and Q-LV
and RV-LV activation time from ECGI map can predict
CRT response pre-procedure * thus can be used to screen and select
patients (prospective randomised controlled study).
The current study will support objective 1) above, and is based on the fact
that the distance be-tween the CRT LV pacing pole and the LV native Late
Activation Zone has previously been shown to correlate to response or
non-response to CRT. We hypothesize that the Amycard 01C surface ECG mapping
system in combination with CT imaging can be used to non-invasively identify
the native LV Late Activation zone and its distance to the CRT LV pacing pole,
and by applying this method in a cohort of patients previously implanted with a
CRT device demon-strate that the Amycard 01C System is being able to predict
non-response to CRT.
The objective of the study is to establish on a statistically significant
number of samples wheth-er the distance between the Late Activation Zone (LAZ),
as identified non-invasively with the Amycard 01C System, and the location of
the LV pacing pole is a predictor of CRT procedure outcome.
Study design
Study Type
Prospective Blinded Multicenter Post-Market Non-Invasive Study assessing lead
placement and native ventricular activation in responding and non-responding
CRT patients.
5.2 Study Sample Size and Study Duration
The investigation will be initiated in Europe and Russia and will utilize
approximately study 6 sites. The goal of the study is to enroll 150 patients
across several sites in the months of November 2020 to June 2021.
Study burden and risks
Risks Associated with the Study Device System
Clinical data from published literature of equivalent devices to the Amycard
01C System, which are certified and are currently placed on the market, have
been evaluated and appraised for clinical safety and performance data.
Therefore, there are no known anticipated AE*s which could be directly related
to the study device or similar CE labelled devices currently available.
Risk-Benefits Analysis
The use of the non-invasive mapping-based CRT protocol using the Amycard 01C
System is in-tended for the acquisition, analysis, display and storage of
cardiac electrophysiological data and maps for analysis by a physician.
It has been judged that the current risk management documentation is consistent
with the clini-cal data presented in the accompanying literature review and
adverse event database search, and that all hazards have been adequately
covered.
Post-market surveillance data obtained from 16 sites where the Amycard 01C
System has been installed and used on a total of 595 patients shows no
complaints or adverse events.
No adverse events related to Amycard 01C System or its equivalent devices were
found in any of the consulted databases. There are no reports of safety-related
issues or side-effects in clini-cal literature relevant to the Amycard 01C
System or its equivalent devices.
Possible risk aasociated with having a CT-scan include but are limited to. Risk
of CT-scan allergic reaction to the contract, side effects to the contracts:
diarrhea, headache, and dizziness. Anxiety, claustrophobia, nephropathy and
radioation exposure.
The amount of radiation for this type of CT scan is below the amount of natural
radiation the patient is exposed to over a 3-year period. The risk of radiation
exposure from a CT might in-crease the risk of cancer to 1 in 2000.
That non-invasive mapping can potentially substitute invasive mapping to assist
the electrophysiologist in the diagnostic process, indicates that both the
device and its study related application have an un-doubtedly positive
risk-benefit profile. They would not cause an electrophysiologist to make a
different diagnosis nor abnormal treatment planning than if the traditional
methods were used.
Considering all available information, the Amycard 01C System does not
compromise the safety of patients, users or other persons, when used under the
conditions and for the purpose
intended.
Avenue des Scienes 13
Yverdon-les-Bains 1400
CH
Avenue des Scienes 13
Yverdon-les-Bains 1400
CH
Listed location countries
Age
Inclusion criteria
1. Appropriately signed and dated informed consent.
2. Age *18 years at time of consent.
3. The presence of a CRT device implanted 6-24 months ago.
4. Patients in Sinus Rhythm or AF with BiV pacing >90%.
5. Patients that fulfilled Class I or Class IIa clinical recommendations per the
ESC Guidelines at the time of implantation.
6. Patients have correctly set pacing parameters (interventricular delay)
according to the ESC Guidelines (QRS duration, Echo).
7. Patients were reliably diagnosed with the cause of heart failure.
8. Patients had a reliable assessment of the degree of cardiac failure before
CRT device implantation and during the follow up period.
Exclusion criteria
1. Patients with acute diseases or exacerbations of chronic diseases; recent
surgery.
2. Patients who have contraindications to CT scanning: excess body weight (BMI
>40)
recent x-ray examination (CT, interventional procedures under fluoros-
copic control), radiation therapy, allergic reactions to iodine,
intolerance
to X-ray contrast agents, kidney diseases with elevated creatinine levels,
(>45)
diseases of the thyroid gland with impaired T3 and T4 levels, difficulties
for venous access, blood clotting disorders.
3. Contraindications to body surface ECG mapping: recent surgery on the
chest, skin diseases, allergic reactions to surface mapping electrodes and
medical band-aid.
4. Patients that have undergone AV nodal ablation and/or are pacemaker
dependent.
5. Pregnant, nursing or planning to become pregnant (documented negative
pregnancy test required documented within a maximum of 7 days prior
to procedure for all women of childbearing potential. Documentation of
effective contraception is also required for women of childbearing po-
tential).
Design
Recruitment
Medical products/devices used
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 | NL75071.068.20 |