A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 738
- 试验地点
- 143
- 主要终点
- Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality
研究概览
简要总结
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Subject has given written informed consent
- •Male or female, at least 18 years of age
- •Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
- •Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, or current European Society of Cardiology (ESC) guidelines for HF treatment in Europe, with any intolerance documented.
- •HF related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening/Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT proBNP) at time of Screening/ Enrollment defined as:
- •Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
- •Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL . Thresholds for NT-proBNP (for both LVEF ≤ 50% and LVEF > 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
- •Subjects should be on diuretic therapy
- •Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader
- •Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient Reader
- •Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
- •Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up
排除标准
- •Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
- •ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
- •Subjects with history of recurrent pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (< 3 month prior to Screening Visit)
- •Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit
- •Unrepaired severe valvular disease
- •Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA sensor or mechanical/tissue right heart valve(s)
- •Subjects with known coagulation disorders
- •Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one-month post implant
- •Known history of life threatening allergy to contrast dye
- •Subjects whereby RHC is contraindicated
- •Subjects with an active infection at the Sensor Implant Visit
- •Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
- •Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
- •Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months
- •Subjects who are pregnant or breastfeeding
- •Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
- •Severe illness, other than heart disease, which would limit survival to <1 year
- •Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
- •Subjects enrolled in another investigational trial with an active treatment arm
- •Subject who is in custody by order of an authority or a court of law
研究组 & 干预措施
Treatment Arm
Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) and Guideline Directed Medical Therapy (GDMT) considering daily Pulmonary Artery Pressure (PAP) measurements and vital signs collected by Cordella Heart Failure System (CHFS).
干预措施: Cordella™ Pulmonary Artery Sensor System (Device)
结局指标
主要结局
Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality
时间窗: 6 months
The primary efficacy endpoint was the 6-month incidence of HF related hospitalizations or all-cause mortality in the modified Intent-to-Treat (mITT) population. As per the approved protocol/CIP, for study success the upper confidence bound of the observed event rate in the mITT population was required to be less than the performance goal (PG) of 0.43 events per patient 6-month, or equivalently, the corresponding p-value from the hypothesis test of 6-month incidence rate compared to PG was less than 0.025. Furthermore, the observed incidence rate was required to be less than 0.37. The 6-month incidence rate was derived using a Poisson regression with the number of events as the dependent variable and the exposure time as an offset term. In these analyses, a subject's exposure time was defined as the time to death, early study discontinuation, or 6 months (whichever occurred first).
Safety: Freedom From Device/System Related Complication
时间窗: 6 months
A device/system related complication (DSRC) is defined as an AE that is, or is possibly, related to the device/system (Cordella PA Sensor or electronic components) and is either treated invasively (other than intramuscular medication or diagnostic RHC) or results in subject´s death or explant of the device. The first primary safety endpoint describes freedom from a DSRC through 6 months and was tested against the null rate of 90%.
Safety: Freedom From Pressure Sensor Failure
时间窗: 6 months
A pressure sensor failure (PSF) occurs when the sensor malfunctions to the point that no readings can be obtained from the sensor after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components. The second primary safety endpoint describes freedom from Pressure Sensor Failure through 6 months, it was tested against the null rate of 95%.
次要结局
- HF Hospitalizations(6 Months prior to implant and 6 months post implant)
- HF Hospitalizations or Emergency Department/Hospital Outpatient IV Diuretic Visits.(6 months)
- Mortality(6 Months)
- IV Diuretic Visits(6 Months)
- Pulmonary Artery Pressure (PAP)(6 months)
- Device Success(6 Months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(6 Months)
- NYHA(6 Months)
- 6-Minute Walk Test(6 Months)
- Number and Percent of Patients With Serious Adverse Events(6 Months)
- Incidence of HF Hospitalizations or All-cause Mortality(12 months)
- N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)(6 months)
- Days Alive and Out of Hospital (DAOH)(6 Months)
- Number of Heart Failure Related Medication Changes(6 Months)
- Number of HF Hospitalization or All-cause Mortality(12 months)
- Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits, All-cause Mortality(6 months)
- Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits(6 months)
- Implant Procedure and Procedure Related Adverse Events and Serious Adverse Events(6 months)