jRCTs052180128已完成不适用
AdaptResponse Clinical Study (AdaptResponse Clinical Study)
未提供0 个研究点目标入组 82 人开始时间: 2014年11月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- combined endpoint of all-cause mortality and intervention for heart failure decompensation
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •1 Subject is willing to sign and date the study Patient Informed Consent (PIC) Form.
- •2 Subject is indicated for a CRT device according to local guidelines.
- •3 Sinus Rhythm at time of enrollment.
- •4 Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Criteria16 for complete LBBB must include:
- •Intrinsic QRS duration >=140 ms (men) or >=130 ms (women), -QS or rS in leads V1 and V2
- •Mid-QRS notching or slurring in >=2 of leads V1, V2, V5, V6, I, and aVL.
- •5 Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
- •6 Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
- •7 NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.
排除标准
- •1 Subject is less than 18 years of age (or has not reached minimum age per local law).
- •2 Subject is not expected to remain available for at least 2 years of follow-up visits.
- •3 Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted.
- •4 Subject is, or previously has been, receiving cardiac resynchronization therapy.
- •5 Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
- •6 Subject has unstable angina or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
- •7 Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
- •8 Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
- •9 Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
- •10 Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
- •11 Subject meets any exclusion criteria required by local law.
结局指标
主要结局
combined endpoint of all-cause mortality and intervention for heart failure decompensation
To test the hypothesis that AdaptivCRT reduces the incidence of the combined endpoint of **all-cause mortality** and **intervention for heart failure decompensation**, compared to standard CRT therapy, in patients with a CRT indication, LBBB and normal AV conduction.
次要结局
未报告次要终点
研究者
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