AquaPass Device in Treatment of CHF Patients

Korábbi kezelés

• Implanted left ventricular assist device or implant anticipated <3 months.

Más betegség

• Subject considered to be in the acute worsening of the heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrythmia, infection or other medical condition unrelated to fluid overload.
• Subject with severe peripheral arterial disease
• History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD).
• Malignancy or other noncardiac condition limiting life expectancy to <12 months.

Laborértékek

• End-stage renal disease (eGFR<15 ml/min/1.73 m2) or requiring dialysis.

Egyéb

• Subject is enrolled to another clinical investigation that might interfere with this study.
• Baseline systolic blood pressure <100 mm Hg
• Subject has any known lower body skin problems (open wounds, ulcers)
• Subject is pregnant or planning to become pregnant within the study period, or lactating mothers.
• Inability or unwillingness to comply with the study requirements.

• Age ≥ 18
• Subject was hospitalized for worsening of chronic heart failure with fluid overload.
• Recruitment with expectation for at least 2 additional days in hospital.
• Subject has composite congestion score ≥3.
• Baseline systolic blood pressure ≥100.
• Subject is capable of meeting the following study requirements:
  • Subject is taking a standing diuretic dose of ≥40 mg/day
  • For patients with BMI <30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP)>1,600 pg/ml
  • For patients with BMI >30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) >800 pg/ml
  • For patients with rate-controlled persistent or permanent Atrial Fibrillation (AF): N-terminal pro b-type natriuretic peptide (NT-proBNP) >2,400 pg/ml.
• Subject completes 2 hours of run-in acclimatization session as follows:
  • Put on the wearable and see if the patient fits inside it comfortably.
  • Turn on console and see if the patient feels well when the skin temperatures are at least 37°C.
  • Blood Pressure, Heart Rate, Core Temperature and have not changed, relative to baseline, by more than 20%.
  • Systolic BP does not drop below 90 mmHg in 2 consecutive measurements.