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

  • STATUS
    Recruiting
  • End date
    Dec 17, 2023
  • participants needed
    30
  • sponsor
    Occlutech International AB
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Updated on 7 October 2022
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heart failure
right ventricular failure
pulmonary arterial pressure

Summary

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

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.

Details
Condition Pulmonary Hypertension
Treatment Occlutech AFR Device
Clinical Study IdentifierNCT03022851
SponsorOcclutech International AB
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

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
2. Severe pulmonary hypertension as evident by echocardiography Echocardiographic
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
Participation in other medical trials shorter than 30 days before the intended AFR
Allergy to anti-platelet, -coagulant, or -thrombotic therapy
Intolerance to contrast agents
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
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
Pregnancy
implantation procedure
Any intracardiac intervention within the last 30 days
Occluded inferior vena cava access
Previous ASD/PFO closure device in place
Intracardiac thrombus
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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