The Prophet Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Hypertension
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ? ...
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.
Tracking Information
- NCT #
- NCT03022851
- Collaborators
- Not Provided
- Investigators
- Not Provided
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