NL-OMON49991撤回不适用
Prospective, non-randomized, pilot study to assess safety and efficacy of a novel Atrial Flow Regulator in patients with Pulmonary Hypertension - AFR-PROPHET trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 6
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
- •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-
- •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
- 另有 1 项未显示
排除标准
- •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
- •7. Pregnancy - (assessed in patients with child bearing potential by urine dip
- •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.
- •itiy and morta
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