NL-OMON53958尚未招募不适用
First In Human Clinical Investigation of the FIRE1* System in Heart Failure Patients_ Pilot Study of the FIRE1TM System in Heart Failure Patients - Clinical Investigation of FIRE1 System in HF Patients -FUTURE HF
FIRE1 (Foundry Innovation and Research 1 Ltd)0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adults aged 18 years or older with a diagnosis of HF for greater than 90
- •days, NYHA Class II or III HF and receiving treatment, in accordance with
- •internationally recognized guidelines and institutional practices to include
- •standard of care drug/device therapies as deemed appropriate.
- •2. a) Have experienced a HF decompensation in the past 12 months prior to
- •consent, defined as either: Hospitalisation for HF, HF treatment in a hospital
- •day-care setting or urgent outpatient HF visit for IV diuretics
- •b) Elevated N-terminal-pro-brain natriuretic peptide (NT-proBNP) >= or brain
- •natriuretic peptide (BNP) within 30 days prior to consent or at screening
- •- Subjects in sinus rhythm NT-proBNP >=800 pg/mL or BNP >=300 pg/mL
- •- Subjects with Atrial Fibrillation (AF) NT-proBNP >=1200 pg/m Lor BNP >=350
- •For subjects treated with an angiotensin receptor neprilysin inhibitor (ARNI)
- •only NT-proBNP values should be considered.
- •3. IVC diameter within the landing zone (between the hepatic and renal veins)
- •of between 14 mm and 28 mm
- •4. Minimum landing zone length of 60 mm.
- •5. Provide informed consent for participation in the clinical investigation and
- •be willing and able to comply with the required assessments, treatment
- •instructions and follow-up visits.
排除标准
- •1. Significant comorbidity or FIRE1* System usability or compliance concern,
- •that would interfere with the ability to safely complete or capably participate
- •in the CIP.
- •2. Patients with an estimated Glomerular Filtration Rate < 30 ml/min at
- •3. Patients that are pregnant or nursing or planning a pregnancy within 1 year
- •of screening.
- •4. Expected lifespan from time of enrolment of < 1 year, as assessed by the
- •Investigator.
- •5. Evidence of advanced, end-stage HF, with NYHA IV, and/or currently treated
- •with intravenous inotropes and/or vasopressors.
- •6. Patients with abdominal circumference of greater than 128 cm at screening.
- •7. Patients who exceed angiographic table weight limit at screening.
- •8. Patients with IVC filter placement in situ, abnormal IVC or femoral venous
- •anatomy, known congenital malformation, absence of IVC, or occlusive or
- •free-floating thrombus in the IVC.
- •9. Patients who have an implantable ventricular assist device (Left Ventricular
- •Assist Device (LVAD), Right Ventricular Assist Device (RVAD) or Biventricular
- •Assist Device (BiVAD) in situ.
- •10. Patients with Cardiovascular Implantable Electronic Device (CIED) implanted
- •<= 3 months prior to screening.
- •11. Patients who have received tissue/organ transplant or planned advanced
- •therapies including a tissue/organ transplant or an implantation of a
- •ventricular assist device within the next 180 days.
- •12. Patients who have planned procedures requiring a venous femoral access
- •within 90 days of the FIRE1* Sensor implantation.
- •13. Patients with echocardiographic evidence of severe tricuspid stenosis or
- •severe tricuspid regurgitation.
- •14. Patients with current echocardiographic evidence of severe aortic valve
- •15. Patients with a known history of thrombophilia or other hypercoagulable
- •16. Patients with venous thrombosis or thromboembolism in the 6 months prior to
- •17. Patients with conditions associated with occlusion of the IVC, iliac or
- •common femoral veins (e.g., venous leg ulcers).
- •18. Patients with hypersensitivity or allergy to aspirin and/or antiplatelet
- •agents used or FIRE1* Gen 2 Sensor components (Nitinol, Polyurethane (PU),
- •Nylon, Polyethylene Terephthalate (PET) and Gold) or contrast media.
- •19. Patients with an active systemic infection at screening.
- •20. Participation in any other concurrent clinical investigation.
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