Last updated on July 2019

Atrial Fibrillation

Brief description of study

Cardiac Resynchronization Therapy (CRT) as a treatment for heart failure has demonstrated benefits in clinical status, reduced heart failure hospitalizations, and improved mortality. However, a persistent rate of non-response and left ventricular lead issues remain, creating an unmet clinical need to provide an alternative for stimulating the left ventricle (LV). To address this unmet clinical need, a new technology, the Wireless Stimulation of the Endocardium (WiSE) System developed by EBR Systems can be applied to patients that have not benefited from CRT, including patients considered non-responders and those that remain untreated due to LV lead related issues. The WiSE System is designed to provide leadless endocardial LV pacing with the ability to select an LV pacing location specific to the individual patient. The technology may benefit the general CRT population as well due to potentially improved outcomes that could occur resulting from patient-specific endocardial site selection and potentially reduced complications and implant failures versus coronary sinus or surgically placed epicardial LV leads.

Eligibility Criteria:

Patients who meet all the following criteria at the time of enrollment may be included:
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) and EF criteria minimum on all classes):
a. Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS≥150ms
b. Class IIa (1): NYHA II, III, IV, EF≤35%, LBBB, QRS≥130 to <150ms
c. Class IIa (2): NYHA II, III, IV, EF≤35%, non-LBBB, QRS≥150ms
2. 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 remailing clinically unchanged or worsened:
a. EF has remained unchanged or worsened, and
b. 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
‘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:
a. Patients in whom CS lead implantation for CRT has failed
b. CS lead implanted but has been programmed OFF
c. High risk upgrades: relative contraindications to CS lead implant
3. Patients on a stable GDMT
4. Patient is in sinus rhythm
5. Patient must be 18 years old or over
6. Patient has signed and dated informed consent

SOLVE CRT EBR Systems - Confidential 4 of 107
Version 1.3–June 28, 2017
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 anitcoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
6. Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within 1 month
7. Patients receiving lithotripsy treatment
8. Life expectancy of < 12 months
9. Chronic hemodialysis
10. Stage 4 or 5 renal dysfunction defined as GFR <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. Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past 1 month
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

Clinical Study Identifier: TX133527

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