About this trial
Prospective, open-label, observational study to evaluate the safety and feasibility of using pulmonary artery pressure (PAP) monitors and wearable activity monitors in patients with pulmonary hypertension (PH).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of pulmonary hypertension (Group I,II,III and IV)
Age 18 years
Estimated glomerular filtration rate (eGFR) > 25
Body mass index (BMI) < 35 (or equivalent)
Disqualifiers
Group IV PH
Active infection
Pulmonary embolus (PE) or deep vein thrombosis (DVT)
Major cardiovascular event within past 2 months
Trial population
Patients with a confirmed diagnosis of PH at right heart catheterisation (RHC) and New York Heart Association (NYHA) class III, prior admission for treatment of heart failure.
Trial design
Cohort
Prospective
Treatments tested in this trial
CardioMEMS HF System
DeviceThe CardioMEMS HF System is the first and only FDA-approved wireless heart failure monitor. The system is a safe, reliable way to help your patients manage their heart failure.
Treatment groups
Trial outcomes
Primary outcomes
Activity Monitors
To test the safety and feasibility of pressure monitoring and wearable activity monitors in patients with PH.
Secondary outcomes
Pulmonary Artery Pressure
To correlate Pulmonary Artery Pressure changes with outcome and activity data.
Sponsors and contacts
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