SIRONA 2 Trial Heart Failure NYHA Class III (NCT04012944) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SIRONA 2 Trial Heart Failure NYHA Class III
Belgium, Germany81 participantsStarted 2019-06-26
Plain-language summary
This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in up to 75 New York Heart Association (NYHA) Class III Heart Failure patients who will receive the Cordella PA Sensor Implant.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has given written informed consent
✓. Male or female, at least 18 years of age
✓. Diagnosis of HF ≥ 6 months with either preserved or reduced left ventricular ejection fraction (LVEF) and NYHA Class III HF at the time of Screening
✓. HF related hospitalization, HF treatment in a hospital day-care setting, or unplanned outpatient clinic HF visit within 12 months prior to consent and/or increase of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) at time of Screening defined as:
✓. Subjects with LVEF \> 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL). Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF \> 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
✓. 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 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
Exclusion criteria
✕. Subjects with primary pulmonary hypertension
✕. Subjects with an active infection at the Cordella PA Sensor Implant Visit
What they're measuring
1
Safety: Freedom from Adverse Events
Timeframe: 30 days
2
Accuracy of Cordella PA Sensor System pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard Right Heart Catheterization (RHC)
✕. Subjects with history of 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 is contraindicated
✕. Implanted with a Cardiac Rhythm Management (CRM) Device (Internal Cardiac Defibrillator (ICD) or pacemaker) or Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) less than 90 days prior to screening visit
✕. Any major surgery within 30 days of the Sensor Implant Visit.
✕. Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min or who are on chronic renal dialysis