Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-06 @ 12:34 PM
Study NCT ID:
NCT03022851
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2017-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prophet Trial -Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
Sponsor:
Occlutech International AB
Organization:
Study Overview
Official Title:
Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFR-Prophet
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIV-16-07-016324 | OTHER | EUDAMED | View |