Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

Part of paid clinical trials in Los Angeles, California.

Sponsor
V-Wave Ltd
Study ID
NCT03838445
Status
Recruiting
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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • V-Wave Interatrial Shunt — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 14, 2020
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Therapy: V-Wave Shunt
    Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation.

Primary Outcome Measure

Safety-Percentage of Treatment patients experiencing major device-related adverse events [ Time Frame: 3 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Keck Medical Center of USCLos AngelesCalifornia90033
Sivagini Ganesh, MD
Sivagini Ganesh, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Marc Simon, MD
Marc Simon, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical Center - Davis Heart & Lung Research InstituteColumbusOhio43210-

Find similar trials in Los Angeles, CA

By research site
Keck Medical Center of USC· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAThe Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute· Columbus, OH

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