NL-OMON38247已完成2 期
ACT Catheter System in Atrial Flutter, Advanced Cardiac Therapeutics: CE Trial Clinical Study - ACT Catheter System trial
Advanced Cardiac Therapeutics, Inc0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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. Suitable candidate for catheter non-emergent intra-cardiac mapping and ablation.
- •2. Eighteen (18) to seventy five (75) years of age
- •3. Signed Informed Consent
排除标准
- •1. Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
- •2. Severe cerebrovascular disease or history of cerebrovascular event (within 1 month)
- •3. Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR <= 29. This is calculated as follows for males:;GFR = (140 - age) x weight x .85 (for females)
- •PCr x 72;where age is specified in years, weight in kg, and PCr is Serum Creatinine in
- •Mg /dL Female GFR is reduced by 15% of the above calculated value for
- •4. Active gastrointestinal bleeding
- •5. Active infection or fever (> 100.5 F/38 C)
- •7. Cardiac surgery within the past two months
- •8. Short life expectancy (< 1 yrs) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease
- •9. Significant anemia (hemoglobin < 8.0 mg / dL)
- •10. Severe uncontrolled systemic hypertension (systolic press. > 240 mm Hg within the last 30 days)
- •11. Documented anaphylaxis during previous exposure to angiographic contrast media
- •12. Uncontrolled congestive heart failure (NYHA Class III or IV)
- •13. Unstable angina or acute myocardial infarction within the past three months
- •14. Bleeding, clotting disorders, or known thrombosis
- •15. Peripheral vascular disease
- •16. Uncontrolled diabetes
- •17. Women who are pregnant and not willing to use contraception for the duration of the study, 30 days
- •18. Active participation in another investigational protocol
- •19. Unable or unwilling to take anti-coagulants
- •20. Unwilling or unable to comply with any protocol or follow up requirements
研究者
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