CTRI/2016/04/006799已完成4 期
AdaptResponse study: a prospective, randomized, controlled,interventional, single-blinded, multi-center, post-market, global Cardiac ResynchronizationTherapy (CRT) in heart failure (HF) clinical study. - AdaptResponse study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
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
入选标准
- •Subject is willing to sign and date the study Patient Informed Consent (PIC) Form.
- •ï?· Subject is indicated for a CRT device according to local guidelines.
- •ï?· Subject has, minimally:
- •o Sinus Rhythm at time of enrollment.
- •o Left Bundle Branch Block (LBBB) as documented on an ECG (within 30
- •days prior to enrollment). Criteria16 for complete LBBB must include:
- •ï?§ Intrinsic QRS duration >=140 ms (men) or >=130 ms (women),
- •ï?§ QS or rS in leads V1 and V2,
- •ï?§ Mid-QRS notching or slurring in >=2 of leads V1, V2, V5, V6, I, and
- •o 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).
- •o Left ventricular ejection fraction less than or equal to 35% (documented
- •within 180 days prior to enrollment).
- •o 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
- •Subject is less than 18 years of age (or has not reached minimum age per local law).
- •ï?· Subject is not expected to remain available for at least 2 years of follow-up visits.
- •ï?· Subject has permanent atrial arrhythmias for which pharmacological therapy and/or
- •cardioversion have been unsuccessful or have not been attempted
- •ï?· Subject is, or previously has been, receiving cardiac resynchronization therapy.
- •ï?· 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
- •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.
- •ï?· Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or
- •valve replacement during the course of the study.
- •ï?· Subject is post heart transplant (subjects on the heart transplant list for the first time are
- •not excluded).
- •ï?· Subject has a limited life expectancy due to non-cardiac causes that would not allow
- •completion of the study.
- •ï?· 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).
- •ï?· Subject meets any exclusion criteria required by local law.
研究者
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