Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronisation Therapy in non responders and previously untreatable patients
‘Non-responder’
Have a CRT system that is functional and despite Guideline Directed Medical Therapy (GDMT), optimal programming the patient has not responded to therapy for a minimum of 6M. Non-response is defined as remaining clinically unchanged or worsened:
- 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
Enrolment Committee
‘Previously Untreatable’: Patients who have a full or partial CRT system,
- Patients in whom CS lead implantation for CRT has failed
- CS lead implanted but has been programmed OFF
- High risk upgrades: relative contraindications to CS lead implant
Current guidelines
- Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS≥150ms
- Class IIa (1): NYHA II, III, IV, EF≤35%, LBBB, QRS≥130 to <150ms
- Class IIa (2): NYHA II, III, IV, EF≤35%, non-LBBB, QRS≥150ms
- Design, 350 patients, 45 Centers
- Prospective, two-arm, randomized, double blind, multi-center
- All patients get WiSE, Randomized 1:1 Sense Mode vs WiSE ON
- Purpose
- To demonstrate the safety and effectiveness of the WiSE
- Indications for Use
- Indicated for CRT Non-Responders or Previously Untreatable and meeting established CRT treatment criteria.
- The WiSE provides endocardial LV stimulation, synchronized to the RV pacing pulse of a commercially-available implanted pacemaker, ICD, CRT-P, or CRT-D to achieve CRT.
Exclusions
- Pure RBBB
- LVEDD ≥ 8cm
- Non-ambulatory or unstable NYHA class IV
- Contraindication to heparin, chronic anticoagulants or antiplatelet agents
- Unstable angina, acute MI, CABG, or PTCA within the past 1 month
- Contraindication to stopping peri-procedural anticoagulation therapy
- Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within 1 month
- Patients receiving lithotripsy treatment
- Life expectancy of < 12 months
- Chronic hemodialysis, Stage 4 or 5 renal dysfunction defined as GFR <30
- Grade 4 mitral valve regurgitation, mechanical aortic valves or TAVR valves
