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This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with severe pulmonary hypertension (PH).
Full 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.
Enrollment
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Inclusion criteria
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
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
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Gönül Sönmez Utkun
Data sourced from clinicaltrials.gov
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