Trials / Completed
CompletedNCT03022851
The Prophet Trial -Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Occlutech International AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with severe pulmonary hypertension (PH).
Detailed description
This study will enroll subjects with severe pulmonary hypertension until a maximum of 30 patients have undergone implantation with the Occlutech® AFR device. Enrolment will be devided in 2 phases. Phase 1: At least 15 adult patients with age ≥ 18 years will be enrolled. Phase 2: Patients with age ≥ 6 years will be enrolled until a maximum of 30 patients is reached.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Occlutech AFR Device | Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure. |
Timeline
- Start date
- 2017-07-19
- Primary completion
- 2024-01-08
- Completion
- 2024-01-08
- First posted
- 2017-01-18
- Last updated
- 2025-11-21
Locations
12 sites across 3 countries: Germany, Poland, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT03022851. Inclusion in this directory is not an endorsement.