The Prophet Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT03022851|
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Device: Occlutech AFR Device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension|
|Actual Study Start Date :||July 19, 2017|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Occlutech AFR Device
Patients who will get the AFR Device implantation
Device: Occlutech AFR Device
Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.
- Absence of Serious Adverse Device Effects (SADES) within 3 month following implantation, including deaths, systemic embolism or device embolizations. [ Time Frame: 0-3 month ]To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.
- Rate of all Serious Adverse Events (SAE) and (Serious) Adverse Device Effects (S)ADEs between 3-12 month post implantation [ Time Frame: 3-12 month ]To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.
- Evidence of a secure placement of the device and of right-to-left shunt through the AFR device immediately after implantation and 3 month and 12 month after procedure. [ Time Frame: 0-12 month ]
The secondary efficacy endpoint will be determined via assessment by color-doppler echocardiography and angiography/fluoroscopy and requires both of:
Device placed in situ [as assessed by the investigator] Evidence of RIGHT TO LEFT shunt through the AFR device [as assessed by the investigator]
- Improvement in number of syncopal events due to pulmonary hypertension in the 3 month, 6 months and 12 month after implantation [ Time Frame: 0-12 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022851
|Contact: Gönül Sönmez Utkunfirstname.lastname@example.org|
|Klinikum der Universität München||Recruiting|
|Munich, Bavaria, Germany, 81377|
|Contact: Nikolaus Haas, Prof.|