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CSP-03035 Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreated Patients (SOLVE CRT)
Description
The WiSE CRT System is an implantable cardiac system to provide LV pacing stimulation in conjunction with a co-implanted system that provides right ventricular stimulation. In combination, the devices deliver Bi-V pacing.
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Eligibility Criteria
Inclusion
- Patient with a class I or IIa (1) or (2) indication for implantation of a (Cardiac Resynchronization Defibrillator) CRT-D device according to current available guidelines AND are either 'Non-Responders' to Cardiac Resynchronization 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:
- Ejection Fraction (EF) has remained unchanged or worsened, and
- 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:
- Patients in whom coronary sinus (CS) lead implantation for CRT has failed
- CS lead implanted has been programmed off due any of the following:
- High risk upgrades: relative contraindications to CS lead implant