Prospective, non-randomized, pilot study to assess safety and efficacy of a novel Atrial Flow Regulator in patients with Pulmonary Hypertension - AFR-PROPHET trial

Occlutech International AB0 sites6 target enrollmentTBD

Overview

Trial never started

Registry

who.int

Start Date

TBD

End Date

May 11, 2022

Last Updated

last year

Study Type

Interventional

Sponsor

•Each patient must fulfill ALL of the following criteria and details: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 understand
•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
•4\. Written, informed consent by the patient or her/his legally\-authorized
•representative for participation in the study.

•A patient must be denied access to the study if one or more of all the
•following criteria are present as evaluated by medical history, laboratory test
•or other, as appropriate: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