TReatment of Pulmonary Hypertension Group II Study (TROPHY-II)

This is an interventional treatment trial for Pulmonary Hypertension (PH) Due to Left Heart Disease Read More

Inclusion Criteria:

• Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
• Male or female, ≥ 18 years of age at the time of screening
• Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
• Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
• Patient with a current diagnosis of NYHA functional class II/III
• Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150μmol/l

Exclusion Criteria:

• Pregnant women or women planning a pregnancy within 12 months of study enrolment
• Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
• Patient with life expectancy of less than a year
• Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
• Patient with pulmonary artery anatomy that precludes treatment
• Patient with moderate to severe pulmonary artery stenosis
• Patient with any pulmonary artery aneurysm
• Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
• Patient experiencing a current episode of acute decompensated heart failure
• Patient who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrolment. Patient who has implantable Cardiomems device, neurostimulators or drug infusion devices, regardless of implant date.