A Prospective, Multi-Center, Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Heart Failure System in (New York Heart Association) NYHA Class III Heart Failure Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure NYHA Class III
- Sponsor
- Endotronix, Inc.
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Efficacy: Accuracy
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
This is a prospective, multi-center, open-label, single-arm feasibility trial to assess device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart failure patients who will receive the Cordella™ Sensor implant.
Detailed Description
The objectives of this study are to establish that the Cordella™ Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant as well as to measure the accuracy of Cordella™ Sensor PA pressure measurements compared with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant. Safety measures will include the frequency and rates of adverse events, both overall and for each specific event, which will be collected throughout the study. Subjects will remain in this trial for 24 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has given written informed consent
- •Male or female, at least 18 years of age
- •Diagnosis of HF ≥ 3 months with either preserved or reduced left ventricular ejection fraction (LVEF)
- •Diagnosis of NYHA Class III HF at the time of Screening with at least 1 HF-related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit within the last year
- •Subjects must be receiving appropriate medical management of HF for 3 months prior to Screening and clinically stable for at least 1 month prior to study entry
- •Subjects with a Body Mass Index (BMI) \< 35 kg/mL2 and chest circumference \< 1050 mm
- •Subjects with right pulmonary artery branch diameter sized between 14 mm and 20 mm (target Sensor implant site) over a length of at least 30mm
- •Subjects with distance between target implant site (right PA branch) and ventral thoracic skin surface of \< 12cm
- •Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 600g) 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.
Exclusion Criteria
- •Subjects with primary pulmonary hypertension.
- •Subjects with an active infection at the Sensor Implant Visit
- •Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
- •Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of the Screening Visit
- •Subjects whereby RHC or computed tomography pulmonary angiography (CTPA) is contraindicated
- •Subjects with a Cardiac Resynchronization Device (CRT), Internal Cardiac Defibrillator (ICD) or pacemaker (if implanted less than 6 months or has more than a single lead), or Left Ventricular Assist Device (LVAD)
- •Any major surgery within 30 days of the Sensor Implant Visit.
- •Subjects with a Glomerular Filtration Rate (GFR) \<30 ml/min or who are on chronic renal dialysis
- •Specific liver enzymes \[Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT) \>3 times the upper limit of normal
- •Subjects likely to undergo lung and/ or heart transplantation within 24 months of the Screening Visit.
Outcomes
Primary Outcomes
Efficacy: Accuracy
Time Frame: 90 days
Accuracy of Cordella™ Sensor PA pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard Right Heart Catheter
Safety Freedom form Adverse events
Time Frame: 30 days
Freedom from adverse events associated with use of the Cordella™ HF System
Secondary Outcomes
- Frequency of Adverse Events(30 days and 2 years)
- Device/system-related complications(30 days and 2 years)
- Pressure sensor failure rate(30 days and 2 years)
- Accuracy of Cordella™ sensor pressure measurements(2 years)
- Change in Pulmonary Artery (PA) pressure(90 days)
- Heart Failure (HF) Hospitalizations(90 days)
- Percentage of device success(90 days)
- Quality of Life measured by Kansas City Cardiomyopathy Questionnaire(90 days and 2 years)
- Quality of Life measured by EuroQOL EQ-5D-5L(90 days and 2 years)
- Adherence to regular myCordella™ Peripherals measurements(90 days and 2 years)