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

Primary Purpose

Pulmonary Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Occlutech AFR Device
Sponsored by
Occlutech International AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age is ≥ 18 / ≥6 years (phase 1 / phase 2).
  2. Patient consents to participation
  3. 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.
  4. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
  5. Patient agrees to comply with the follow-up schedule.
  6. Patient has had a successful BAS procedure and is in a stable hemodynamic state, as assessed by the investigator.
  7. Conventional treatment options for the patient are exhausted according to ESC and AHA guidelines.
  8. 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.
  9. "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
  10. "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

  1. Local or generalized sepsis or other acute infection(s)
  2. Thrombophilic coagulation disorder
  3. Allergy to nickel and/or titanium and/or nickel/titanium-based materials
  4. Allergy to anti-platelet, -coagulant, or -thrombotic therapy
  5. Intolerance to contrast agents
  6. Participation in other medical trials shorter than 30 days before the intended AFR implantation procedure
  7. Pregnancy - (assessed in patients with child bearing potential by urine dip stick)
  8. Any intracardiac intervention within the last 30 days
  9. 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

Sites / Locations

  • Klinikum der Universität MünchenRecruiting
  • Elisabeth Krankenhaus
  • Justus-Liebig UniversitätRecruiting
  • Universitätsklinikum WürzburgRecruiting
  • University of GroningenRecruiting
  • St. Antonius ZiekenhuisRecruiting
  • Gdański Uniwersytet MedycznyRecruiting
  • Uniwersytet Jagielloński Collegium MedicumRecruiting
  • Szpital im. Fryderyka ChopinaRecruiting
  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu MedycznegoRecruiting
  • Hacettepe Üniversitesi Tıp FakültesiRecruiting
  • Ankara Dışkapı Yıldırım Beyazıt HastanesiRecruiting
  • Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
  • Ege Üniversitesi Tıp Fakültesi Hastanesi
  • Sağlık Bilimleri Üniversitesi Tepecik Eğitim ve Araştırma HastanesiRecruiting
  • Kocaeli Üniversitesi Araştırma ve Uygulama HastanesiRecruiting
  • Sivas Cumhuriyet Üniversitesi Tıp Fakültesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Occlutech AFR Device

Arm Description

Patients who will get the AFR Device implantation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2017
Last Updated
September 5, 2022
Sponsor
Occlutech International AB
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1. Study Identification

Unique Protocol Identification Number
NCT03022851
Brief Title
The Prophet Trial -Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
Acronym
AFR-Prophet
Official Title
Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Occlutech International AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Occlutech AFR Device
Arm Type
Experimental
Arm Description
Patients who will get the AFR Device implantation
Intervention Type
Device
Intervention Name(s)
Occlutech AFR Device
Intervention Description
Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.
Primary Outcome Measure Information:
Title
Absence of Serious Adverse Device Effects (SADES) within 3 month following implantation, including deaths, systemic embolism or device embolizations.
Description
To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.
Time Frame
0-3 month
Secondary Outcome Measure Information:
Title
Rate of all Serious Adverse Events (SAE) and (Serious) Adverse Device Effects (S)ADEs between 3-12 month post implantation
Description
To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.
Time Frame
3-12 month
Title
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.
Description
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]
Time Frame
0-12 month
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gönül Sönmez Utkun
Phone
+902124650497
Email
clinicaltrials@occlutech.com
Facility Information:
Facility Name
Klinikum der Universität München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaus Haas, Prof.
Facility Name
Elisabeth Krankenhaus
City
Essen
Country
Germany
Individual Site Status
Completed
Facility Name
Justus-Liebig Universität
City
Giesen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Jux, MD
Phone
+49 (0) 641/985-43461
Email
christian.jux@paediat.med.uni-giessen.de
First Name & Middle Initial & Last Name & Degree
Christian Jux, MD
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Nordbeck, MD
Phone
+49 (0)-931 201-39004
Email
Nordbeck_P@ukw.de
First Name & Middle Initial & Last Name & Degree
Peter Nordbeck, MD
Facility Name
University of Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. M. Berger, MD
Phone
+31 (0) 50 361 2800
Email
r.m.f.berger@umcg.nl
First Name & Middle Initial & Last Name & Degree
R. M. Berger, MD
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martijn C. Post, MD
Phone
+31 30 6099111
Email
m.post@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Martijn C. Post, MD
Facility Name
Gdański Uniwersytet Medyczny
City
Gdańsk
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Sabiniewicz, MD
Phone
‭+48 695 687 587‬
Email
sabini@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Robert Sabiniewicz, MD
Facility Name
Uniwersytet Jagielloński Collegium Medicum
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Kopeć, MD
Phone
+48 12 614 33 99
Email
grzegorzkrakow1@gmail.com
First Name & Middle Initial & Last Name & Degree
Grzegorz Kopeć Kopeć, MD
Facility Name
Szpital im. Fryderyka Chopina
City
Otwock
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcin Kuzyna, MD
Phone
+48-22-7103052
Email
marcin.kurzyna@gmail.com
First Name & Middle Initial & Last Name & Degree
Marcin Kurzyna, MD
Facility Name
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Lesiak, MD
Phone
+48 61 854 91 46
Email
maciej.lesiak@skpp.edu.pl
First Name & Middle Initial & Last Name & Degree
Maciej Lesiak, MD
Facility Name
Hacettepe Üniversitesi Tıp Fakültesi
City
Altındağ
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ergün Barış Kaya, MD
Phone
+90 533 778 72 60
Email
doctorkaya@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ergün Barış Kaya, MD
Facility Name
Ankara Dışkapı Yıldırım Beyazıt Hastanesi
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan Güllü, MD
Phone
+90 5320521426
Email
drgullu@gmail.com
First Name & Middle Initial & Last Name & Degree
Hakan Güllü, MD
Facility Name
Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
City
Istanbul
Country
Turkey
Individual Site Status
Completed
Facility Name
Ege Üniversitesi Tıp Fakültesi Hastanesi
City
İzmir
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Sağlık Bilimleri Üniversitesi Tepecik Eğitim ve Araştırma Hastanesi
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barış Kılıçaslan, MD
Phone
+90 505 588 81 88
Email
kilicaslan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Barış Kılıçaslan, MD
Facility Name
Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi
City
Kocaeli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teoman Kılıç, MD
Phone
+90 (0) 262303 7335
Email
teoman.kilic@kocaeli.edu.tr
First Name & Middle Initial & Last Name & Degree
Teoman Kılıç, MD
Facility Name
Sivas Cumhuriyet Üniversitesi Tıp Fakültesi
City
Sivas
Country
Turkey
Individual Site Status
Withdrawn

12. IPD Sharing Statement

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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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