Eligibility Details:
Inclusion/Exclusion:
Inclusion Criteria
1. 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)):
1. Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
2. Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to < 150ms
3. Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
2. Patient is a:
1. '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 6 months. Non-response is defined as:
- EF has remained unchanged or worsened (defined as < 5% increase since
implant), 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
OR
2. '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:
i. 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
ii. 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
c. '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
3. Patients on a stable Guideline Directed Medical Therapy (GDMT)
4. Patient must be 18 years old or over
5. Patient has signed and dated informed consent
6. 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)
Exclusion Criteria
Patients who meet any one of these criteria will be excluded from the investigation:
1. Pure RBBB
2. LVEDD ≥ 8cm
3. Non-ambulatory or unstable NYHA class IV
4. Contraindication to heparin, chronic anticoagulants or antiplatelet agents
5. Triple anticoagulant patients who cannot tolerate peri-procedural stopping of
anticoagulation therapy
6. Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant
within prior 30 days.
7. Patients with planned or expected lithotripsy treatment post implant
8. Life expectancy of < 12 months
9. Chronic hemodialysis
10. Stage 4 or 5 renal dysfunction defined as eGFR < 30
11. Grade 4 mitral valve regurgitation
12. Noncardiac implanted electrical stimulation therapy devices
13. Mechanical aortic valves or TAVR valves
14. Unstable angina, acute MI, CABG, or PTCA within the past 1 month
15. Correctable valvular disease that is the primary cause of heart failure
16. Recent CVA or TIA (within the previous 3 months)
17. Atrial fibrillation/flutter: Patients with a history of paroxysmal or persistent
atrial fibrillation/flutter may be included if they have been in sinus rhythm for the
past 30 days, and have not had cardioversion in the past 30 days. Patients with AV
node ablation may be included if they have not had symptomatic atrial
fibrillation/flutter in the last 30 days, and have not had cardioversion in the past
30 days.
18. Already included in another clinical study that could confound the results of this
study
19. Pregnancy
20. Known drug or alcohol addiction or abuse
21. Moderate or severe aortic stenosis
22. 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
23. Patient will not tolerate being randomized to the Control Group for 6 months
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
