Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

Prior treatment

• Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
• Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
• Patients with planned or expected lithotripsy treatment post implant
• Noncardiac implanted electrical stimulation therapy devices
• Recent CVA or TIA (within the previous 3 months)
• Known drug or alcohol addiction or abuse

Other illness

• Unstable angina, acute MI, CABG, or PTCA within the past 1 month
• Correctable valvular disease that is the primary cause of heart failure
• Patients with a history of paroxysmal or persistent atrial fibrillation/flutter are excluded if they have had a documented AF episode \> 30 min or a cardioversion in the past 1 month.

Lab values

• Stage 4 or 5 renal dysfunction defined as eGFR \< 30

Other

• Patients who meet any one of these criteria will be excluded from the investigation:
• Pure RBBB
• LVEDD ≥ 8cm
• Non-ambulatory or unstable NYHA class IV
• Contraindication to heparin, chronic anticoagulants or antiplatelet agents
• Life expectancy of \< 12 months
• Chronic hemodialysis
• Grade 4 mitral valve regurgitation
• Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
• Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
• Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing \<95%)
• Already included in another clinical study that could confound the results of this study
• Pregnancy
• Moderate or severe aortic stenosis
• Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, or to comply with the trial's procedures
• For Part II Randomized patients only, those who will not tolerate being randomized to the Control Group for 6 months

• Patient with a class I or IIa (1) or (2) indication for implantation of a CRT-D device according to current available guidelines (with additional QRS criteria on Class IIa (1)):
  • 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
• Patient is a:
  • a.'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 CS lead implantation for CRT has failed
  • CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, persistent phrenic nerve pacing, or other procedural challenges
  • CS lead implanted but has been programmed OFF
  • LV lead that was implanted but not operational includes patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, phrenic nerve pacing, lead failure, lead dislodgement, or sub-optimal LV lead location
  • OR
  • 'High Risk Upgrade:
  • Patients who have a relative contraindication to CS lead implant, due to:
  • venous occlusion or lesion precluding implant
  • pocket infection risk (at co-implanted device site)
  • considered high risk for CS implant due to co-morbidities
• Patients on a stable Guideline Directed Medical Therapy (GDMT)
• Patient must be 18 years old or over
• Patient has signed and dated informed consent
• Patient has suitable anatomy for implant of the WiSE CRT System (e.g. adequate acoustic window, LV wall thickness in target implant area ≥ 5 mm, absence of LV wall structural abnormalities which may preclude implant)

Criteria the registry did not label

• Inclusion/Exclusion: