NL-OMON33252已完成不适用
A multi-center study of the safety and efficacy of the percutaneous transvenous mitral annuloplasty system to reduce mitral valve regurgitation in patients with heart failure. - Ptolemy-2
Viacor Inc.0 个研究点目标入组 14 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
- 已完成
- 发起方
- 入组人数
- 14
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. Patient has moderate functional MR: regurgitant orifice area >/= 0.20cm2 or regurgitant volume >/= 30 mL/beat or regurgitant fraction >/= 30%.
- •2. Symptomatic heart failure NYHA Class II to IV
- •3. LV dysfunction (25% < LVEF < 50% by echocardiography)
- •4. Age >/= 50 Years.
- •5. Patient has signed the informed consent agreement.
排除标准
- •Exclusion Criteria
- •1. Mitral regurgitation of organic origin such as: degenerative disease (prolapse), rheumatic disease (commissural fusion, shortening and thickening of the subvalvular apparatus), endocarditis, flail segments, congenital mitral disease, significant annular calcification, significant pathology of the chords.
- •2. Severe mitral leaflet tethering.
- •3. Valvular apparatus cannot be visualized by 2D transthoracic echo. Valvular regurgitation cannot be quantified by 2D echo PISA or Doppler techniques.
- •4. Serious allergy to intravenous contrast agents or serious renal dysfunction (glomerular filtration rate less than 30 ccs/minute, as calculated by the Cockroft-Gult equation), or otherwise major contra-indication for contrast angiography.
- •5. History of myocardial infarct (MI) within 60 days prior to study procedure.
- •6. History of PCI within 60 days prior to study procedure.
- •7. Patient is not capable of walking 100 meters in 6 minutes.
- •8. Patient cannot complete the QOL survey with a meaningful score.
- •9. Indication of left-dominant coronary circulation with angiography.
- •10. Significant (>30% occluded) Left Main stenoses or proximal circumflex stents unless affected area has been by-passed surgically.
- •11. Indication of non-patent CSO or discontinuous CS-GCV-AIV with venography, MRI, or cardiac CT.
- •12. Planned CABG or mitral valve surgery or planned biventricular pacemaker requiring placement of leads in the coronary sinus.
- •13. Existing bi-ventricular pacemaker with leads in the coronary sinus or its tributaries. Presence of instrumentation that in the clinician*s judgment will either impede safe placement of the study device, and/or will be dislodged or will malfunction as a result of placement of the study device.
- •14. Existing prosthetic mitral valve implant or annuloplasty ring.
- •15. Acute systemic infection (including septicemia or leukocytosis greater than 15,000/dL), active infections including endocarditis or fever greater than 38.5° C.
- •16. Chronic steroid use or intravenous steroid use within the past 60 days.
- •17. Major organ system disease such as hepatic dysfunction including cirrhosis, esophageal varices, or severe chronic obstructive pulmonary disease (COPD), at least GOLD stage III or greater.
- •18. History of major thrombo-embolic event within past three months (i.e. cerebral-vascular event, stroke, pulmonary or arterial embolism).
- •19. Existing bleeding diathesis: elevated PT INR (>1.5), elevated aPTT, platelet count <100,000, unless this can be adjusted with a change to existing medication.
- •20. Patient refuses blood products.
- •21. Patient has a significant gastrointestinal (GI) bleed within the past three months.
- •22. Uncontrolled thyroid disease.
- •23. Severe autoimmune system disease or history of hypercoagulable state.
- •24. Participation in a drug or device trial if such participation would impact the PTMA* study and follow-up.
- •25. Life expectancy of less than 1 year or any condition which, based on the investigator*s clinical judgment, would prevent the patient from completing required study procedures, including follow-up.
- •26. Female patients of childbearing potential if lactating, or with a positive pregnancy test within 7 days of planned procedure.
- •27. Patient requires emergency surgery, or is clinically unstable due to such causes as hemodynamic instability or significant active and uncontrolled angina.
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