♥ Aktuelle Studien

(Endovascular NeuromoDulation Treatment fOr Heart Failure)
A Prospective, Multicenter, Open Label, Single Arm, Study to Assess the Safety & Performance of the Harmony Aortic Stimulation System (HASS) for the Treatment of Heart Failure

• Age: 18 - ≤ 85years
• Subject is a male or a postmenopausal female, or a female of childbearing age for whom pregnancy or breastfeeding was excluded and who has accepted to use adequate contraception measures for the entire study duration.
• NYHA class II-III.
• LVEF≥40% and diagnosed as Heart failure with midrange or preserved Ejection according to the guidelines.
• Elevated NT-proBNP >300pg/mL. Persistent atrial fibrillation: NT-proBNP ≥450 pg/mL.
• Stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrolment.
• Average Heart rate 60 - 110 b/min (24-h ECG)
• Subject is capable to walk a distance of 150-450 m in 6 minutes hall walk test.
• Subject is willing to and capable of providing informed consent.
• Subject is capable of participating in all tasks associated with this clinical investigation.
• Subject can comply with catheterization lab standard of care procedures.

• CRT, Pacemaker or an ICD.
• Uncontrolled symptomatic brady-arrhythmias or unstable ventricular arrhythmias.
• 1st degree AV block with PR interval > 240msec, 2nd or 3rd degree AV block.
• COPD or severe restrictive lung disease (e.g., requires chronic steroid use or home oxygen use)
• Body Mass Index (BMI) ≥ 40 kg/m²
• Renal insufficiency (eGFR<25 ml/min/1.73 m²)
• Thoracic aorta’s abnormalities or diseases (e.g. aneurysm, dissection, extensive plaque, implanted stent or stent graft)
• Thoracic aorta’s anatomy is not compatible with the Harmony’s implant (e.g. aortic diameter or morphology) based on CT scan analysis.
• Subject’s thorax anatomy does not enable adequate communication between implant and the external patient unit based on CT scan analysis.
• Severe valvular (Mitral or Aortic) disease (e.g. severe stenosis or regurgitation).
• Prior cardiac transplant or heart transplant candidate.
• Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty, cerebral vascular accident, transient ischemic attack or coronary artery bypass graft within 90 days prior to enrolment.
• Expected cardiac surgery or percutaneous cardiac intervention (e.g. coronary and valves) during the study period.
• Heart failure is due to congenital heart disease.
• Subject is unable to take anticoagulants or antiplatelet agents.
• Subject has infiltrative or restrictive cardiomyopathy.
• Marfan syndrome.
• Subject is allergic to iodine or contrast media.
• Diseases or conditions which, in the judgment of the PI, preclude participation in the clinical investigation.
• Life expectancy of <12 months, per PIs'decision.