CRT-DRIVE: Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment

Cardiac resynchronization therapy (CRT) is considered an established
non-pharmacological treatment for heartfailure (HF). However, clinical research
efforts continue with the goal to further improve CRT clinical efficacy.
The standard 12-lead electrocardiogram (ECG) is the most routinely used,
inexpensive, and non- invasive modality to record the electrical activity of
the heart, but its diagnostic capability has acknowledged limits.
Non-invasive electrocardiographic imaging, also called ECGI mapping, overcomes
at least some of the limitations of the standard ECG. However, ECGI mapping
relies on a large number of electrodes, placed on the patient*s torso at the
time of geometry acquisition using cardiac imaging as well as during the
clinical intervention, thus requiring dedicated technical support and
additional costs. Therefore, despite the advantages, its adoption in the
clinical workflow is still limited.
More recently, a novel approach has been developing which enables to
reconstruct the activation map relying only on the 12-lead ECG for the electric
data, by taking advantage of physiological and anatomical knowledge implemented
in a patient-specific model. The fitted patient-specific model can calculate
almost real-time the activation sequence and may therefore enable
model-assisted therapeutic intervention.
XSpline® Cloud is a cloud-based Software as a Medical Device for medical
professionals, specifically cardiologist.
The software XSpline® Cloudis provided in form of a platform, a stand-alone
medical software package used to collect, archive and display clinical
information and health documentation referring to CRT-destined patients.
XSpline® Cloud, given DICOM CT images of torso and heart, and given digital 12-
lead electrocardiogram, provides visual 3D information about heart anatomy and
the morphology of coronary vein through an automatic segmentation procedure of
cardiac structures. Additionally, it generates an epi- and endocardial
electrical activation map, which provides an opportunity to visualize the
latest activation zone and reach the target zone for successful CRT
implantation. It is therefore an active medical device- non therapeutic - used
for image and data elaboration purposes in the office of the physician. The
clinical benefits expected for CRT-destined patients is to receive the
intervention with higher prior knowledge of the surgeon regarding heart and
veins anatomy and electrical functionality, with the potential of a more
accurate intervention and reduced time.

The primary objective of the CRT-DRIVE study is to test the hypothesis that at
least 75% of patients undergoing a CRT implantation guided by non-invasive
electrical and venous anatomy assessment (XSPLINE technology) will show a
reduction of left ventricular end-systolic volume of 15% or more at 6-month
evaluation.

This is a prospective, multicenter controlled study. Enrolled patients are
eligible for CRT as part of their standard of care and, additionally, meet all
the other inclusion criteria and do not meet any of the exclusion criteria.
After the 6-months follow-up visit, all included and treated patients will
complete and exit the study. No further follow-up visit is envisioned
thereafter

For patients, the risk implicit in the participation in the clinical
investigation is the possible malfunction of the web connection and/or the
software. As a result, the Investigator can be provided with invalid data. This
potential issue is minimized by using data exchange protocols with various data
protection protocols, vasty checked though intensive testing that protects
transfer and integrity of data. Image quality of output data (resolution,
orientation, artefacts) is checked, extensively tested, improved using robust
image improvement algorithms and validated.
In addition, patient personal information is not required for the use of the
device. Whenever patient information is present on uploaded images, that is
overwritten by a codification during the upload, therefore no patient
information is stored.
By participating in this clinical investigation, patients will benefit from the
use of a tool that will provide the Investigator with more precise mapping of
electrical activity of the heart and of coronary venous anatomy. This will help
in a more appropriate positioning of the LV lead and cannulation of the
coronary sinus. This will contribute to reduction of total procedure length and
fluoroscopy time

Risks from Electrocardiogram (ECG)
The ECG test is a recording of the electrical activity of the heart. The sticky
pads used may be cold when applied and sometimes cause discomfort such as
redness or itching. If the hair under the patches needs to be shaved,
irritation from shaving also could occur.
Risks from Computerized Tomography (CT)
A CT scan is a series of cross-sectional X-rays that will be taken of the
heart. CT scans expose the patient to more radiation than a standard X-ray, but
the risk of complication including cancer associated with this irradiation is
small. Some people have a reaction to the contrast dye that is injected into a
vein before the scan, as it contains iodine. Allergy to iodine may cause
nausea, sore throat, vomiting, sneezing, itching or hives. A severe allergic
reaction (called anaphylaxis) that results in difficulty breathing can occur,
but it is rare.
Disadvantages of this study such as physical complications are no different
from patients not participating in this study.