Pulmonary HypertensionAFR-ProphetNCT03022851
The Prophet Trial -Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
A study testing Occlutech AFR Device in people with Pulmonary Hypertension, run by Occlutech International AB at 12 sites in 3 countries.
Trial summary
This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with severe pulmonary hypertension (PH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Occlutech AFR Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 19 Jul 2017to 7 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- "Syncope"(Group A-PH) 9.1. Syncope due to acute PH episodes (as defined by exclusion of other causes) 9.2. Other causes of syncope must have been actively excluded 9.3. Syncope (Black-out) or pre-syncope (episodic dizziness) >2 last 3 months 9.4. PH (defined as mean pulmonary artery pressure > 25 mmHg, or pulmonary vascular resistance of > 3 Wood Units) must exist, RV-failure is however not a prerequisite
- "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.
- 10.2. 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.
Who cannot join
- 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
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- 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
- 1. 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
- 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
- Any intracardiac intervention within the last 30 days
- Occluded inferior vena cava access
- Previous ASD/PFO closure device in place
- Intracardiac thrombus
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Turkey (Türkiye)5 sites
Hacettepe Üniversitesi Tıp Fakültesi
Ankara, Altındağ, 06230
Ankara Etlik Şehir Hastanesi
Ankara, Yenimahalle, 06170
Ege Üniversitesi Tıp Fakültesi Hastanesi
Izmir, Bornova, 35100
Sağlık Bilimleri Üniversitesi Tepecik Eğitim ve Araştırma Hastanesi
Izmir, Konak, 35020
Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi
Kocaeli
Poland4 sites
Gdański Uniwersytet Medyczny
Gdansk, 80-952
Uniwersytet Jagielloński Collegium Medicum
Krakow, 31-202
Szpital im. Fryderyka Chopina
Otwock, 05-400
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego
Poznan, 61-848
Germany3 sites
Justus-Liebig Universität
Giesen, 35385
Klinikum der Universität München
Munich, Bavaria, 81377
Universitätsklinikum Würzburg
Würzburg, 97080
About this study
Official title: Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with severe pulmonary hypertension (PH).
Read the 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Occlutech AFR Device
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlutech AFR DeviceDevice
Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.
| Study group | Role | What they receive |
|---|---|---|
| Occlutech AFR Device | Experimental | Patients who will get the AFR Device implantation Receives: Device: Occlutech AFR Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.
Measured: 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.
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]
Measured: 0-12 month
Improvement in number of syncopal events due to pulmonary hypertension in the 3 month, 6 months and 12 month after implantation
Measured: 0-12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start19 Jul 2017
- Primary completion8 Jan 2024
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022851
- Sponsor's protocol ID
- Occ2016_04
- Other IDs
- CIV-16-07-016324
- Acronym
- AFR-Prophet
- Status last verified
- Sep 2022
- First submitted
- 10 Jan 2017
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03022851
- Acronym / sponsor ID
- AFR-Prophet / Occ2016_04
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occlutech AFR Device | Experimental | Device: Occlutech AFR DevicePatients who will get the AFR Device implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlutech AFR DeviceCatheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure. | Device | Occlutech AFR Device |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlutech AFR Device in people with Pulmonary Hypertension, run by Occlutech International AB at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Turkey (Türkiye), Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of Serious Adverse Device Effects (SADES) within 3 month following implantation, including deaths, systemic embolism or device embolizations. (time frame: 0-3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.