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

Withdrawn

Conditions: high blood pressure in the lungs
Pulmonary hypertension
10037454

Registration Number: NL-OMON49991

Lead Sponsor: Occlutech International AB

Brief Summary: Trial never started

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

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
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
European Society of Cardiology and American Heart Association guidelines
8. SpO2 >= 86 % (pulsoxymetric measurement)Further, the patient must fulfill ALL
criteria and details of
EITHER *Syncope* (Group-A-PH) OR *RV-Failure* (Group B-PH).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) TAPSE10.3. Severe
pulmonary hypertension as evident by CATH
CATH-data:
10.3.1. Mean RA pressure (RAP) >= 10 mmHg 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
atrial septostomy (BAS) and before AFR device implantation
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Exclusion Criteria

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
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 > 12mmORProcesses 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 thrombusORany 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 in general.
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