MedTrace Logo

The Prophet Trial -Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension

NCT03022851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-11-21

No results posted yet for this study

Summary

This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with severe pulmonary hypertension (PH).

Conditions

  • Pulmonary Hypertension

Interventions

DEVICE

Occlutech AFR Device

Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.

Sponsors & Collaborators

  • Occlutech International AB

    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
2017-07-19
Primary Completion
2024-01-08
Completion
2024-01-08

Countries

  • Germany
  • Poland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03022851 on ClinicalTrials.gov