NCT02922036进行中（未招募）不适用
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 68
- 主要终点
- Primary Efficacy 1
研究概览
简要总结
This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
详细描述
The WiSE-CRT System is an implantable cardiac pacing system capable of delivering pacing energy to the left ventricle of the heart without using a pacing lead.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
One part of the study was randomized. The final part of the study was single-arm, open label.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion/Exclusion:
- •Inclusion Criteria
- •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:
- •'Non-responder' [Not Enrolling]: 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
- •'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
- •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
- •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)
排除标准
- •Patients who meet any one of these criteria will be excluded from the investigation:
- •LVEDD ≥ 8cm
- •Non-ambulatory or unstable NYHA class IV
- •Contraindication to heparin, chronic anticoagulants or antiplatelet agents
- •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
- •Life expectancy of < 12 months
- •Chronic hemodialysis
- •Stage 4 or 5 renal dysfunction defined as eGFR < 30
- •Grade 4 mitral valve regurgitation
- •Noncardiac implanted electrical stimulation therapy devices
- •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
- •Unstable angina, acute MI, CABG, or PTCA within the past 1 month
- •Correctable valvular disease that is the primary cause of heart failure
- •Recent CVA or TIA (within the previous 3 months)
- •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.
- •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
- •Known drug or alcohol addiction or abuse
- •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
研究组 & 干预措施
Treatment
Experimental
WiSE System therapy ON with Guideline Directed Medical Therapy
干预措施: WiSE System (Device)
结局指标
主要结局
Primary Efficacy 1
时间窗: 6 Months
Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.
Primary Safety
时间窗: 6 Months
Freedom from Procedure and Device System related Type 1 Complications
次要结局
- Secondary Efficacy 3(6 months)
- Secondary Efficacy 2(6 Months)
- Secondary Efficacy 5(6 months)
- Secondary Efficacy 1(6 Months)
- Secondary Efficacy 4(6 months)
研究者
研究点 (68)
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