The primary objectives of this investigation are to evaluate whether pre-acquired Amycard ECGI map-guided LV lead placement (I) improves CRT volumetric response compared to non-guided (empiric) LV lead placement, and (II) reduces the distance to LV…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this investigation are:
• Left Ventricular End-Systolic Volume index (LVESVi) (mL/m2) mean reduction of
additional >=30% (active arm) compared to empiric CRT LV lead implantation
(control arm) at 6 months post-implantation versus baseline measured by
transthoracic echocardiography.
• The proportion of patients in the ECGI map-guided (active) arm having a
distance from the active pole of the LV lead to LV LEAS at 6 months follow-up <=
47 mm being significantly higher than in the non-guided (empiric lead
placement) arm (control arm).
Secondary outcome
Secundary endpoints:
• Rate of Amycard 01C associated AEs.
• Rate of correctly predicted distance of venous access within <=47 mm to
the LV LEAS using the baseline pre-CRT implant Amycard ECGI map
in the Active Arm.
• The degree of LV LEAS shift between baseline and the 6-month follow-up.
• Accuracy of early activation site reconstruction, measured at 6-month
follow-up.
Descriptive endpoints, including but not limited to:
• LVESVi (mL/m2) reduction (%) in subjects with LV lead distance <=47 mm
from the LV LEAS in the Control Arm compared to the Active Arm at
6 months post-implantation.
• The Clinical Composite Score (CCS) at 6 months post-implantation based
on:
o Mortality rate
o HF hospitalization rate
o Patient Global Assessment questionnaire
• The Left Ventricular Ejection Fraction (LVEF) (%) at 6 months
post-implantation compared to baseline.
• Actual distance between the LV lead active pole and the LV native
rhythm LEAS at 6 months post-implantation
• Non-responder rate at 6 months post-implantation
o Where CRT response is defined as: a decrease in left ventricular
(LV) end*systolic volume (LVESV) of >=15% and/or absolute increase of 5%
in LVEF (%) at the 6*month visit
• ECGI acquisition procedural failure rate
• ECGI acquisition time
• Total CRT implant time (incision-to-closure time)
• Subgroup analysis based on conditions or habits such as: ischemia vs
non-ischemia, arrhythmias, diabetes, smoking,
renal disease, QRS duration native rhythm, NYHA Class, gender, age,
baseline LVESV, baseline EF, hypertension, pulmonary hypertension,
COPD, impaired RV function, cerebrovascular disease, peripheral
vascular disease, and HF related medication
• The degree of LV LEAS shift between baseline and the 6-month follow-up.
• The practice change effected by ECGI measured by the pre-CRT implant
and post-CRT implant Investigator Questionnaire.
o The proportion of plan changes assessed by comparing the implanters
pre-CRT intended target LV lead location and the actual targeted LV
lead location.
Background summary
Cardiac Resynchronization Therapy improves cardiac function, symptoms, and
well-being, and reduces morbidity and mortality in an appropriately selected
group of HF patients. While CRT is an effective therapy, approximately 30% of
patients treated with CRT do not respond to the therapy.
Previous clinical data have indicated that the distance between the LV pacing
site and site of LV latest electrical activation (LV LEAS) is a strong
independent predictor for CRT response. A potential strategy for improving CRT
outcome could be to optimize the left ventricular lead placement (LVLP) by
using electrocardiographic imaging (ECGI).
Electrocardiographic imaging (ECGI) is a noninvasive mapping and imaging
modality for cardiac electrophysiology (EP). ECGI determines noninvasively and
with high resolution the electrical activity of the heart from electrical data
recorded on the body surface together with cardiac CT images.
ECGI mapping provides valuable information for guiding the CRT lead placement
during implantation. The technology may optimize CRT therapy, eventually
leading to a better selection of patients for CRT, overall improving the
outcome of CRT procedures, resulting in a reduction of the current CRT failure
rate.
The main purpose of this study is to assess whether ECGI map-guided left
ventricular lead placement (LVLP) improves CRT outcome at 6 months
post-implantation in de-novo CRT patients. The ECGI mapping is generated with
the CE marked Amycard 01C System.
Study objective
The primary objectives of this investigation are to evaluate whether
pre-acquired Amycard ECGI map-guided LV lead placement (I) improves CRT
volumetric response compared to non-guided (empiric) LV lead placement, and
(II) reduces the distance to LV LEAS compared to non-guided (empiric) lead
placement.
Study design
A multicenter randomized controlled study to assess patient response to CRT
comparing ECGI map guided left ventricular lead placement with empirical lead
placement.
Intervention
For the active arm group:
ECGI mapping (paired with a CT scan) of the heart, prior to CRT implantation
and 6 months after CRT implantation.
For the control group:
ECGI mapping (paired with a CT scan) of the heart, 6 months after CRT
implantation.
Study burden and risks
Amycard 01C System Related:
Subjects may experience skin irritation when applying the electrodes for
perfoprming the ECGI mapping with the Amycard 01C system.
CT-scan related:
The estimated radiation dose of a native CT-thorax (high tube voltage) + heart
(Coronary Computed Tomography Angiography (FLASH)) is approximately 4-6mSv for
both of these scans in total.
Subjects in the Active group will undergo the CT-scan twice (i.e. 2x 4-6mSv =
8-12mSv), whereas subjects in the Control group will undergo the CT-scan once
(i.e. 4-6mSv).
The amount of radiation for this type of CT-scan will be comparable to the
amount of natural radiation the patient is exposed to over a 3-year period
(i.e. 2-5 mSv a year).
The load and/or risks to which subjects are exposed in this study are
considered to be low to negligible.
Avenue des Sciences 13
Yverdon-les-Bains 1400
CH
Avenue des Sciences 13
Yverdon-les-Bains 1400
CH
Listed location countries
Age
Inclusion criteria
Eligible subjects must meet all of the following criteria to be included in the
study:
1. Appropriately signed and dated informed consent.
2. Age >=18 years at time of consent.
3. Considered stabilized after >=3 months of optimal medical therapy before
screening
4. Patient in Sinus Rhythm at the time of screening, having LBBB per ESC
guidelines 2013.
a. QRS duration >=120ms
b. QS or rS in lead V1
c. Broad (frequently notched or slurred) R waves in leads I, aVL, V5, or V6
d. Absent Q waves in leads V5 and V6
5. Patient is intended for placement of a CRT device with biventricular (BiV)
pacing.
Exclusion criteria
Subjects that meet any of the following criteria will be excluded from the
study: 1. Currently implanted with pacemaker or ICD with >20% RV pacing in the
past 3 months. 2. Acute diseases or exacerbations of chronic diseases (as per
the investigator*s discretion) 3. Contraindications to CT-scanning 4.
Contraindications to body surface ECG mapping: o ongoing wound healing on the
chest (e.g. recent surgery) o skin diseases o allergic reactions to surface
mapping electrodes and medical band-aid 5. Pregnant, or subjects planning to
become pregnant within 24 months after signing informed consent o A documented
negative pregnancy test (serum or blood) is required for women of childbearing
potential. 6. Incapacitated individuals, defined as persons who are mentally
ill, mentally handicapped, or individuals without legal authority, are excluded
from the study population
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 |
|---|---|
| ClinicalTrials.gov | NCT05564793 |
| CCMO | NL82710.100.23 |