NL-OMON55596招募中不适用
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients - SOLVE CRT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 6 months. Non-response is defined as remailing clinically
- •unchanged or worsened:
- •a. EF has remained unchanged or worsened (defined as < 5% increase
- •since implant), 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 (Site Enrollment Committee
- •of at least one electrophysiologist and a designated Heart Failure Specialist
- •*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
- •. High risk upgrades:patients with relative contraindications to CS lead
- •3. Patients on a stable GDMT
- •4. Patient must be 18 years old or over
- •5. Signed and dated informed consent
- •6. Patient has suitable anatomy for implant of the WiSE CRT System (e.g.
- •acoustic window, LV wall thickness in target implant area >= 5 mm, absence of LV
- •structural abnormalities which may preclude implant)
排除标准
- •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 must be excluded
- •6. Patients with planned or expected lithotripsy treatment post-implant
- •7. Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful
- •co-implant
- •within the prior 30 days
- •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. Patients with a prosthetic aortic valve and a non-viable transseptal
- •approach for the electrode implant.
- •14. Patients with a prosthetic mitral valve and a non-viable transseptal
- •approach for the electrode implant
- •15. Unstable angina, acute MI, CABG, or PTCA within the past 1 month
- •16. Correctable valvular disease that is the primary cause of heart failure
- •17. Recent CVA or TIA (within the previous 3 months)
- •18. Patients with a history of paroxysmal or persistent atrial
- •fibrilation/flutter are excluded if they have had a documented
- •AF episode > 30 min or a cardioversion in the past 30 days from screening.
- •19. Patients with permanent AF are excluded if they have intact AV node
- •conduction (RV pacing >95%)
- •20. Already included in another clinical study that could confound the results
- •of this study
- •21. Pregnancy
- •22. Known drug or alcohol addiction or abuse
- •23. Moderate or severe aortic stenosis
- •24. Positive test for COVID-19 at screening
- •25. 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
- •26. For Part II randomized patients, those who will not tolerate being
- •randomized to the Control Group for 6 months
研究者
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