Trials / Withdrawn
WithdrawnNCT05205265
Rivet PVS Therapy in Group 2 PH-HFpEF
Safety and Efficacy of the Rivet Pulmonary-to-Venous Shunt (PVS) Therapy in Patients With Group 2 Pulmonary Hypertension (PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- NXT Biomedical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Rivet Shunt | The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach |
Timeline
- Start date
- 2022-05-10
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2022-01-25
- Last updated
- 2024-06-03
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05205265. Inclusion in this directory is not an endorsement.