Trials / Active Not Recruiting
Active Not RecruitingNCT05077774
Harmony TPV Post-Approval Study
Harmony TPV Post-Approval Study (Harmony PAS2)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Harmony TPV System | Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS) |
Timeline
- Start date
- 2021-10-25
- Primary completion
- 2026-08-01
- Completion
- 2035-03-01
- First posted
- 2021-10-14
- Last updated
- 2026-01-08
Locations
20 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05077774. Inclusion in this directory is not an endorsement.