Rivet PVS Therapy in Group 2 PH-HFpEF
NCT05205265 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-06-03
Summary
This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.
Conditions
- Heart Failure
- Pulmonary Hypertension
Interventions
- DEVICE
-
Rivet Shunt
The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach
Sponsors & Collaborators
-
NXT Biomedical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-10
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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