- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03022851
The Prophet Trial -Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension (AFR-Prophet)
Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gönül Sönmez Utkun
- Phone Number: +902124650497
- Email: clinicaltrials@occlutech.com
Study Locations
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Essen, Germany
- Completed
- Elisabeth Krankenhaus
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Giesen, Germany
- Recruiting
- Justus-Liebig Universität
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Contact:
- Christian Jux, MD
- Phone Number: +49 (0) 641/985-43461
- Email: christian.jux@paediat.med.uni-giessen.de
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Principal Investigator:
- Christian Jux, MD
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Würzburg, Germany
- Recruiting
- Universitatsklinikum Wurzburg
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Principal Investigator:
- Peter Nordbeck, MD
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Contact:
- Peter Nordbeck, MD
- Phone Number: +49 (0)-931 201-39004
- Email: Nordbeck_P@ukw.de
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Bavaria
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Munich, Bavaria, Germany, 81377
- Recruiting
- Klinikum der Universität München
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Contact:
- Nikolaus Haas, Prof.
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Groningen, Netherlands
- Recruiting
- University of Groningen
-
Contact:
- R. M. Berger, MD
- Phone Number: +31 (0) 50 361 2800
- Email: r.m.f.berger@umcg.nl
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Principal Investigator:
- R. M. Berger, MD
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Nieuwegein, Netherlands
- Recruiting
- St. Antonius Ziekenhuis
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Contact:
- Martijn C. Post, MD
- Phone Number: +31 30 6099111
- Email: m.post@antoniusziekenhuis.nl
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Principal Investigator:
- Martijn C. Post, MD
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Gdańsk, Poland
- Recruiting
- Gdański Uniwersytet Medyczny
-
Contact:
- Robert Sabiniewicz, MD
- Phone Number: +48 695 687 587
- Email: sabini@gumed.edu.pl
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Principal Investigator:
- Robert Sabiniewicz, MD
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Kraków, Poland
- Recruiting
- Uniwersytet Jagiellonski Collegium Medicum
-
Contact:
- Grzegorz Kopeć, MD
- Phone Number: +48 12 614 33 99
- Email: grzegorzkrakow1@gmail.com
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Principal Investigator:
- Grzegorz Kopeć Kopeć, MD
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Otwock, Poland
- Recruiting
- Szpital im. Fryderyka Chopina
-
Contact:
- Marcin Kuzyna, MD
- Phone Number: +48-22-7103052
- Email: marcin.kurzyna@gmail.com
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Principal Investigator:
- Marcin Kurzyna, MD
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Poznań, Poland
- Recruiting
- Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
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Contact:
- Maciej Lesiak, MD
- Phone Number: +48 61 854 91 46
- Email: maciej.lesiak@skpp.edu.pl
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Principal Investigator:
- Maciej Lesiak, MD
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Altındağ, Turkey
- Recruiting
- Hacettepe Üniversitesi Tıp Fakültesi
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Contact:
- Ergün Barış Kaya, MD
- Phone Number: +90 533 778 72 60
- Email: doctorkaya@yahoo.com
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Principal Investigator:
- Ergün Barış Kaya, MD
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Ankara, Turkey
- Recruiting
- Ankara Dışkapı Yıldırım Beyazıt Hastanesi
-
Contact:
- Hakan Güllü, MD
- Phone Number: +90 5320521426
- Email: drgullu@gmail.com
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Principal Investigator:
- Hakan Güllü, MD
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Istanbul, Turkey
- Completed
- Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
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Kocaeli, Turkey
- Recruiting
- Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi
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Contact:
- Teoman Kılıç, MD
- Phone Number: +90 (0) 262303 7335
- Email: teoman.kilic@kocaeli.edu.tr
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Principal Investigator:
- Teoman Kılıç, MD
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Sivas, Turkey
- Withdrawn
- Sivas Cumhuriyet Üniversitesi Tıp Fakültesi
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İzmir, Turkey
- Active, not recruiting
- Ege Üniversitesi Tıp Fakültesi Hastanesi
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İzmir, Turkey
- Recruiting
- Sağlık Bilimleri Üniversitesi Tepecik Eğitim ve Araştırma Hastanesi
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Principal Investigator:
- Barış Kılıçaslan, MD
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Contact:
- Barış Kılıçaslan, MD
- Phone Number: +90 505 588 81 88
- Email: kilicaslan@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- "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.
Exclusion Criteria
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
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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Occlutech AFR Device
Patients who will get the AFR Device implantation
|
Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0-3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
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] |
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
|
0-12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Occ2016_04
- CIV-16-07-016324 (Other Identifier: EUDAMED)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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