NL-OMON53966尚未招募不适用
Evaluation of the safety, efficacy and cost-effectiveness of transcatheter tricuspid valve repair in patients with severe tricuspid regurgitation in the Netherlands. - TRACE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The patient is symptomatic (NYHA Functional Class II, III or ambulatory
- •class IV) despite Standard Of Care (SOC). The Central Screening Committee (CSC)
- •will assess whether the patient is receiving Standord Of Care (SOC), which for
- •TR is limited to symptomatic treatment with diuretics. The CSC will also ensure
- •that in case of the presence of atrial fibrillation, left sided heart valve
- •disease (not requiring intervention) or coronary artery disease, these
- •conditions are treated adequately with medication and/or intervention/device
- •2. The patient suffers from >= grade 3 isolated TR as determined by the
- •assessment of a qualifying TTE and 3DTEE and confirmed by the CSC, according to
- •PCR Tricuspid Focus Group consensus document (in press). Note: If cardiac
- •procedure(s) occur after eligibility was determined, TR grade will be
- •re-assessed 30 days after the procedure.
- •3. The cardiac surgeon of the sites* local heart team concurs that the patient
- •is at high estimated risk for mortality or morbidity with TV surgery.
- •4. The patient is >=18 years of age at time of consent.
- •5. The patient must provide written IC prior to any trial related procedure.
排除标准
- •1. Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary
- •pulmonary hypertension as assessed by RHC. Severe uncontrolled hypertension
- •Systolic Blood Pressure (SBP) >= 180 mmHg and/or Diastolic Blood Pressure (DBP)
- •>= 110 mmHg.
- •2. Any condition that would interfere with a TTVr procedure, such as prior
- •tricuspid valve repair or tricuspid valve leaflet anatomy which may preclude
- •device implantation (e.g. calcification in grasping area, a severe coaptation
- •defect of the tricuspid leaflets (non-clippable), pacemaker or Implantable
- •Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement
- •or visualization of TTVr devices, Ebstein Anomaly (normal annulus position, but
- •valve leaflets attached to walls and septum of RV), tricuspid valve anatomy non
- •evaluable by echo, known allergy or hypersensitivity to dual antiplatelet
- •therapy AND anticoagulant therapy or to device materials, femoral venous mass
- •or thrombus or vegetation.
- •3. Indication for left-sided (e.g. severe aortic stenosis, severe mitral
- •regurgitation) or pulmonary valve correction within prior 60 days. Note:
- •concomitant mitral valve disease (e.g. mitral regurgitation) will be treated
- •first and patients will be reassessed for the trial after 60 days.
- •4. Tricuspid valve stenosis - Defined as a tricuspid valve orifice of <= 1.0 cm2
- •and/or mean gradient >=5 mmHg.
- •5. Left Ventricular Ejection Fraction (LVEF) <=20%
- •6. Active endocarditis, active rheumatic heart disease, other ongoing infection
- •requiring antibiotic therapy (enrolment possible 30 days after discontinuation
- •of antibiotics with no active infection) or leaflets degenerated from
- •rheumatic disease (i.e. noncompliant, perforated)
- •7. Myocardial infarction known unstable angina, or percutaneous coronary
- •intervention within prior 30 days.
- •8. Hemodynamic instability defined as systemic systolic pressure <90 mmHg with
- •or without afterload reduction, cardiogenic shock or the need for inotropic
- •support or hemodynamic support device (e.g. intra-aortic balloon pump).
- •9. Cerebrovascular Accident (CVA) within prior 90 days
- •10. Chronic dialysis
- •11. Bleeding disorders or hypercoagulable state, inability to use dual
- •antithrombotic therapy due to contraindication, allergy or hypersensitivity
- •12. Active peptic ulcer or active gastrointestinal (GI) bleeding
- •13. Life expectancy of less than 12 months
- •14. Subject currently participating in another clinical trial (not yet
- •completed primary endpoint) or in another clinical investigation for valvular
- •heart disease.
- •15. Pregnant or nursing patients or those who plan pregnancy during the course
- •of the trial. Women of childbearing age are required to have a negative
- •pregnancy test 7 days prior to baseline visit. Women of childbearing age should
- •be instructed to use safe contraception or have a sterilized regular
- •16. Presence of anatomic or comorbid conditions, or other medical, social or
- •psychological conditions that, in the eye of the investigator, limits the
- •subject*s ability to participate in the clinical investigation or comply with
- •follow-up requirements, or impact the scientific soundness of the investigation
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