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

September 5, 2022 updated by: Occlutech International AB

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).

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Essen, Germany
        • Completed
        • Elisabeth Krankenhaus
      • Giesen, Germany
      • Würzburg, Germany
        • Recruiting
        • Universitatsklinikum Wurzburg
        • Principal Investigator:
          • Peter Nordbeck, MD
        • Contact:
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • Klinikum der Universität München
        • Contact:
          • Nikolaus Haas, Prof.
      • Groningen, Netherlands
        • Recruiting
        • University of Groningen
        • Contact:
        • Principal Investigator:
          • R. M. Berger, MD
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Martijn C. Post, MD
      • Gdańsk, Poland
        • Recruiting
        • Gdański Uniwersytet Medyczny
        • Contact:
        • Principal Investigator:
          • Robert Sabiniewicz, MD
      • Kraków, Poland
        • Recruiting
        • Uniwersytet Jagiellonski Collegium Medicum
        • Contact:
        • Principal Investigator:
          • Grzegorz Kopeć Kopeć, MD
      • Otwock, Poland
        • Recruiting
        • Szpital im. Fryderyka Chopina
        • Contact:
        • Principal Investigator:
          • Marcin Kurzyna, MD
      • Poznań, Poland
        • Recruiting
        • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
        • Contact:
        • Principal Investigator:
          • Maciej Lesiak, MD
      • Altındağ, Turkey
        • Recruiting
        • Hacettepe Üniversitesi Tıp Fakültesi
        • Contact:
        • Principal Investigator:
          • Ergün Barış Kaya, MD
      • Ankara, Turkey
        • Recruiting
        • Ankara Dışkapı Yıldırım Beyazıt Hastanesi
        • Contact:
        • Principal Investigator:
          • Hakan Güllü, MD
      • Istanbul, Turkey
        • Completed
        • Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
      • Kocaeli, Turkey
        • Recruiting
        • Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi
        • Contact:
        • Principal Investigator:
          • Teoman Kılıç, MD
      • Sivas, Turkey
        • Withdrawn
        • Sivas Cumhuriyet Üniversitesi Tıp Fakültesi
      • İzmir, Turkey
        • Active, not recruiting
        • Ege Üniversitesi Tıp Fakültesi Hastanesi
      • İzmir, Turkey
        • Recruiting
        • Sağlık Bilimleri Üniversitesi Tepecik Eğitim ve Araştırma Hastanesi
        • Principal Investigator:
          • Barış Kılıçaslan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2017

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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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