Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients (SOLVE CRT)

The WiSE-LV System is an implantable cardiac pacing system capable of delivering pacing
energy to the left ventricle of the heart without using a pacing lead.

Inclusion Criteria:

- Patient with a class I or IIa (1) or (2) indication for implantation of a (Cardiac
Resychronization Defibrillator) CRT-D device according to current available guidelines
AND are either 'Non-Responders' to Cardiac Resychronization Therapy (CRT) OR
'Previously Untreatable' (described below):

- Non-Responder: Patients who have a CRT system that is functional and despite an
adequate trial of Guideline Directed Medical Therapy (GDMT) and attempts at
optimal device programming the patient has not responded to therapy for a minimum
of 6M. Non-response is defined as remaining clinically unchanged or worsened:

1. Ejection Fraction (EF) has remained unchanged or worsened, and

2. The patient's clinical status based in the totality of available clinical
evidence (such as NYHA Class, exercise tolerance, QOL, or global assessment)
has remained unchanged or worsened, as determined by the local Site
Enrollment Committee.

- Previously Untreatable: Patients who have a full or partial CRT system, who meet
general inclusion criteria and are deemed as 'previously untreatable' for one of
the following reasons:

1. Patients in whom coronary sinus (CS) lead implantation for CRT has failed

2. CS lead implanted has been programmed off due any of the following:

3. High risk upgrades: relative contraindications to CS lead implant

Exclusion Criteria:

- Pure Right Bundle Branch Block (RBBB)

- Left Ventriculart Diastolic Diameter (LVEDD) ≥ 8cm

- Non-ambulatory or unstable NYHA class IV

- Contraindication to heparin, chronic anticoagulants or antiplatelet agents

- Triple anitcoagulant patients who cannot tolerate peri-procedural stopping of
anticoagulation therapy must be excluded

- Patients receiving lithotripsy treatment

- Attempted device implant (pacemaker, Implantable cardioverter defibrillator (ICD),
CRT, Left ventricular (LV) lead) or successful co-implant within 1 month

- Life expectancy of < 12 months

- Chronic hemodialysis

- Stage 4 or 5 renal dysfunction defined as Glomerular Filtration Rate (GFR) <30

- Grade 4 mitral valve regurgitation

- Noncardiac implanted electrical stimulation therapy devices

- Mechanical aortic valves or transcatheter aortic valve replacement (TAVR) valves

- Unstable angina, acute myocardial infarction (MI), coronary artery bypass graft
(CABG), or percutaneous transluminal coronary angioplasty (PTCA) within the past 1
month

- Correctable valvular disease that is the primary cause of heart failure

- Recent cerebrovascular accident (CVA) or transient ischemic attack (TIA) (within the
previous 3 months)

- Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation)
within the past month

- Already included in another clinical study that could confound the results of this
study

- Pregnancy

- Known drug or alcohol addiction or abuse

- Moderate or severe aortic stenosis