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

NCT03022851 | Completed DMC

• 2 other identifiers: Occ2016_04CIV-16-07-016324
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 12

Brief Summary

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

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Absence of Serious Adverse Device Effects (SADES) within 3 month following implantation, including deaths, systemic embolism or device embolizations.

  To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.

  0-3 month

Secondary Outcomes (3)

• Rate of all Serious Adverse Events (SAE) and (Serious) Adverse Device Effects (S)ADEs between 3-12 month post implantation

  3-12 month

• 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.

  0-12 month

• Improvement in number of syncopal events due to pulmonary hypertension in the 3 month, 6 months and 12 month after implantation

  0-12 month

Study Arms (1)

Occlutech AFR Device

EXPERIMENTAL

Patients who will get the AFR Device implantation

Device: Occlutech AFR Device

Interventions

Occlutech AFR Device DEVICE

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

Occlutech AFR Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is ≥ 18 / ≥6 years (phase 1 / phase 2).
• Patient consents to participation
• The patient or his/her legal representative should have the ability to fluently speak and under-stand the language in which the study is being conducted. If the patient speaks a different language, then a sentence-to-sentence translation for unequivocal understanding must be provided.
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
• Patient agrees to comply with the follow-up schedule.
• Patient has had a successful BAS procedure and is in a stable hemodynamic state, as assessed by the investigator.
• Conventional treatment options for the patient are exhausted according to ESC and AHA guidelines.
• SpO2\> 86 % pulsoxymetric measurement) This document is confidential and property of Occlutech. It´s only for clinical personnel, Ethical committees and third person in direct contact with the clinical responsible. It is not allowed to distribute information contained in this document without the permission of Occlutech unless the information is already published.
• "RV-Failure"(Group B-PH) 10.1. Right heart failure, chronic and clinically severe 10.1.1.NYHA class III or worse 10.1.2. 6 min walk \< 320 m 10.1.3. Signs of venous congestion (distended veins, edema, ascites, etc) 10.1.4.Symptomatic disease resulting in 1 or more PH-related hospitalization over the last 12 months. Elective hospital admissions solely for the purpose of performing diagnostic procedures do not count for this.
• Severe pulmonary hypertension as evident by echocardiography Echocardiographic: 10.2.1. RV larger than LV; 10.2.2. RA larger than LA; 10.2.3. atrial septum bulging into left atrium 10.2.4.ventricular septum bulging into the left ventricle 10.2.5.Reduced (below age-related normal mean value) TAPSE 10.3. Severe pulmonary hypertension as evident by CATH CATH-data: 10.3.1.Mean RA pressure (RAP) of \> 10 and ≤ 20 mmHg; 10.3.2.Mean LA pressure (LAP) \< 15 mmHg 10.3.3.Mean RAP \> mean LAP; 10.3.4.Mean pulmonary arterial pressure \>25 mm Hg 10.3.5. Echocardiographically demonstrated continuous right to left shunt following balloon aterial septostomy (BAS) and before AFR device implantation.

You may not qualify if:

• Processes which interfere medically with invasive device implantation
• Local or generalized sepsis or other acute infection(s)
• Thrombophilic coagulation disorder
• Allergy to nickel and/or titanium and/or nickel/titanium-based materials
• Allergy to anti-platelet, -coagulant, or -thrombotic therapy
• Intolerance to contrast agents
• Participation in other medical trials shorter than 30 days before the intended AFR implantation procedure
• Pregnancy - (assessed in patients with child bearing potential by urine dip stick)
• Any intracardiac intervention within the last 30 days
• Thickness of atrial septum \> 12mm OR Processes which would technically disturb the safe intervention as planned
• \. Occluded inferior vena cava access 2. Previous ASD/PFO closure device in place 3. Intracardiac thrombus OR any other circumstance that, in the opinion of the Investigator,
• might interfere with the implantation, might affect the patient's well-being thereafter or might interfere with the conduct and follow up within the Study is general.
• Local or generalized sepsis or other acute infection(s)
• Thrombophilic coagulation disorder
• Allergy to nickel and/or titanium and/or nickel/titanium-based materials

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (12)

Klinikum der Universität München

Munich, Bavaria, 81377, Germany

Location

Justus-Liebig Universität

Giesen, 35385, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Gdański Uniwersytet Medyczny

Gdansk, 80-952, Poland

Location

Uniwersytet Jagielloński Collegium Medicum

Krakow, 31-202, Poland

Location

Szpital im. Fryderyka Chopina

Otwock, 05-400, Poland

Location

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego

Poznan, 61-848, Poland

Location

Hacettepe Üniversitesi Tıp Fakültesi

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Ege Üniversitesi Tıp Fakültesi Hastanesi

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Sağlık Bilimleri Üniversitesi Tepecik Eğitim ve Araştırma Hastanesi

Izmir, Konak, 35020, Turkey (Türkiye)

Location

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 18, 2017
• Study Start: July 19, 2017
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: November 21, 2025

Record last verified: 2022-09

Locations

DE (3); PL (4); TU (5)