Active Clinical Trials
Vascular Interventions/Innovations and Therapeutic Advances (VITA); A study to Explore the feasibility of using Combined Modalities to test the Safety of CardioMEMS Device in PAH Patients
Four unique innovations will arise out of this Stage A of the VITA contract: 1) The first use of the implantable CardioMEMS® ambulatory hemodynamic sensor in PAH to monitor disease progress 2) The first combined use of the CardioMEMS® sensor with cardiac MRI to develop a unique right ventricular-pulmonary arterial coupling element 3) The first use of the CardioMEMS system to obtain exercise hemodynamics 4) The testing of a unique machine leaning software, ALiE, to decipher patterns real time in longitudinal hemodynamic data and other prognostic variables, which may predict outcome in PAH. Each innovation, if proven feasible in this phase of the VITA contract will then be tested and validated in a future Stage B application as unique prognostic factors in PAH. It is our hope that these innovations will serve as superior surrogate markers for outcome prediction and monitoring of treatment efficacy that will lead to an improvement survival and quality of life for our patients.
- Written informed consent obtained from subject
- Male or female, at least 18 years of age
- Diagnosis of PAH (WHO group 1 PH). Both naÃ¯ve and prior treated patients are included.
- Patients with at least WHO/NYHA Class III symptoms with a heart failure related hospitalization within the last year.
- Subjects with pulmonary artery branch inner diameter sized > 7mm and in a descending branch within the left or right lower lobe (target implant vessel)
- Subjects willing and able to comply with the follow up requirements of the study
- Subjects with an active infection
- Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- Subjects, in the Investigatorâ€™s opinion, unable to tolerate a right heart catheterization
- Subjects likely to undergo lung transplantation within 6 months of Screening Visit
- Subjects with mechanical right heart valve(s)
- Subjects with a true allergy to aspirin, and/or clopidogrel who are not on or a candidate for Coumadin for their PAH or other cardiovascular conditions
- Subjects whose clinical condition, in the Investigatorâ€™s opinion, would not allow them to complete the study