CompletedNot Applicable

SIRONA Trial Heart Failure NYHA Class III

Belgium, Ireland15 participantsStarted 2017-12-01

Plain-language 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.

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 ≥ 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

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

What they're measuring

Safety Freedom form Adverse events

Timeframe: 30 days

Efficacy: Accuracy

Timeframe: 90 days

Trial details

NCT IDNCT03375710

SponsorEndotronix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-28

View on ClinicalTrials.gov More Heart Failure NYHA Class III trials