NCT05332873撤回不适用
Safety and Efficacy of the Rivet Pulmonary-to-Venous Shunt (PVS) Therapy in Patients With Group 2 Pulmonary Hypertension (PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)
NXT Biomedical2 个研究点 分布在 1 个国家开始时间: 2023年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Rate of Major Adverse Events
研究概览
简要总结
This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Select Inclusion Criteria:
- •Age ≥ 18 years
- •Prior diagnosis of Group 2 PH due to HFpEF, with at least one of the following resting hemodynamic criteria confirmed in the past year by right heart catheterization
- •mPAP > 20 mmHg at rest
- •mPAP/CO slope > 3 mmHg/L/min with exercise
- •Confirmation of the following hemodynamic criteria during supine exercise: PCWP ≥ 25 mmHg, or PCWP/CO slope > 2 mmHg/L/min
- •Chronic symptomatic heart failure documented by the following:
- •NYHA HF Class II with history > II, or Class III, or ambulatory Class IV
- •≥ 1 HF hospitalization, or healthcare facility with IV diuretics or intensification of oral diuresis for HF within 12 months, or NT-pro BNP value > 400 pg/mL in normal sinus rhythm or > 750 pg/mL in atrial fibrillation in past 6 months
- •Ongoing stable guideline directed medical therapy (GDMT) for HF and medically optimized per treating cardiologist according to current ACCF/AHA guidelines that is expected to be maintained without change for 1 month (excluding diuretic dosage changes for HF optimization within 30 days of the Index Procedure)
- •6MWD ≥ 100 m
排除标准
- •Any therapeutic intracardiac intervention within the last 30 days
- •PH Group 1, 3, 4 or 5
- •Mean RAP >16 mmHg by RHC at rest on room air
- •Right ventricular dysfunction, defined as one or more of the following
- •Greater than moderate RV dysfunction as assessed by TTE and/or MRI
- •RV FAC < 35%
- •TAPSE < 14 mm via TTE
- •RV size severely enlarged compared to LV size as estimated by TTE and/or MRI
- •Severe tricuspid valve regurgitation
- •Peak systolic pulmonary arterial pressure > 80 mmHg by RHC at rest while awake
- •Mean pulmonary arterial pressure > 50 mmHg by RHC at rest while awake
- •PVR > 6 Wood units at rest while awake on room air
- •Left ventricular ejection fraction < 50%
- •Severe heart failure, defined as one or more of the following:
- •ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
- •If BMI < 30, Cardiac Index < 2.0 L/min/m2
- •If BMI ≥ 30, Cardiac Index < 1.8 L/min/m2
- •Requires continuous intravenous inotropic infusion
- •Requires mechanical circulatory support
- •Currently on the cardiac transplant waiting list
- •Chronic renal dysfunction defined as: eGFR < 35 mL/min/1.73 m2 by the CKD-Epi equation
- •Chronic pulmonary disease defined as one or more of the following:
- •Requires continuous home oxygen therapy
- •Recent hospitalization for exacerbation within 12 months prior to screening
- •FEV1 < 50% predicted
结局指标
主要结局
Rate of Major Adverse Events
时间窗: 1 month
Composite of major adverse cardiac, cerebrovascular, or renal events (MACCRE) and re-intervention for study device related complications at implantation procedure (Day 0) and up to 1-month post-procedure (Day 30)
Rate of Technical Success of the Rivet Shunt Implantation Procedure
时间窗: At time of procedure
Study device is implanted as intended and confirmation of a patent pulmonary-to-venous shunt between the RPA and SVC by qualitative assessment via angiography and/or echocardiography at implantation procedure.
次要结局
- Change in RV Chamber Size at 12 months - Diameter(12 months)
- Change in Hemodynamics at 12 months - PCWP(12 Months)
- Change in Kansas City Cardiomyopathy Questionnaire(12 months)
- Adverse Events through 12 months(12 months)
研究者
研究点 (2)
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