Pulmonary Arterial Hypertension
Conditions
Keywords
Pulmonary Arterial Hypertension, PAH, Interatrial Shunt, Interatrial Shunting, Atrial Septostomy
Brief summary
The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.
Detailed description
This is a multi-national, multi-center, prospective, non-randomized, open label trial of patients implanted with the study device. A total of up to 20 patients will be implanted with the study device and followed at regular intervals for 1 year and then annually for a total of 5 years post implant.
Interventions
DEVICEV-Wave Interatrial Shunt
The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovals and straddles the interatrial septum.
Sponsors
V-Wave Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease). 2. WHO Functional Class III or IV symptoms. If WHO Class III, at least 1 High-Risk characteristic or 2 Intermediate-Risk characteristics from the 2015 ESC Guidelines. 3. Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month. Main
Exclusion criteria
1. Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude. 2. Mean Right Atrial Pressure \>20 mmHg. 3. Severe restrictive or obstructive lung disease. 4. Evidence of organ dysfunction other than right heart failure. 5. Left ventricular ejection fraction \<40 %. 6. Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum. 7. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent. 8. Hemodynamic heart rhythm, or respiratory instability at time of Final
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety-Percentage of Treatment patients experiencing major device-related adverse events | 3 months | Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation |
| Safety-Percentage of Treatment patients experiencing any major adverse event | 3 months | Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation |
| Procedure Success-Percentage of patients successfully implanted with study device | 3 months | Percentage of patients successfully implanted with the study device at the intended location across the interatrial septum during the index procedure compared to patients with attempted implantations |
| Device Success-Percentage of patients implanted with right to left interatrial flow | 3 months | Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device related MACNE at 1 and 12 months after implantation | 1 and 12 months | Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation. |
| Improvement in Exercise Capacity between baseline and 12 months | 12 months | Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months |
| Improvement in WHO Functional Class between baseline and 12 months | 12 months | Improvement in World Health Organization Functional Class between baseline and 12 months. |
| Improvement in Quality of Life between baseline and 12 months | 12 months | Improvement in Quality of Life as measured by the SF-36 questionnaire |
Countries
Mexico, United States
Contacts
PRINCIPAL_INVESTIGATORVictor Tapson, M.D.
Cedars-Sinai Medical Center
Outcome results
None listed