AdaptResponse study: a prospective, randomized, controlled,interventional, single-blinded, multi-center, post-market, global Cardiac ResynchronizationTherapy (CRT) in heart failure (HF) clinical study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- the composite of all-cause death and any intervention for heart
研究概览
简要总结
The primary objective of the AdaptResponse Study is to test the hypothesis that
AdaptivCRT
® reduces the incidence of the combined endpoint of all-cause mortality andintervention for heart failure decompensation, compared to standard CRT therapy, in
patients with a CRT indication, LBBB and normal AV conduction. Intervention for heart
failure decompensation (HF event) is defined as an event requiring “
*invasive intervention(i.e. IV diuretics, ultrafiltration, or equivalent) or inpatient hospitalizationâ€.*The study will be event driven, comparing the rate of first events. The study will continue
until a predetermined number of events have been observed, unless the DMC advises to
stop earlier.
The analysis will include all randomized patients and will follow the intent-to-treat principle.
A secondary analysis will be done including only the patients for whom the ECG Core
Laboratory confirmed the presence of LBBB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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:  Intrinsic QRS duration ≥140 ms (men) or ≥130 ms (women),  QS or rS in leads V1 and V2, and  Mid-QRS notching or slurring in ≥2 of leads V1, V2, V5, V6, I, and aVL.
- •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 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.
结局指标
主要结局
the composite of all-cause death and any intervention for heart
时间窗: 2 years after enrollment
failure decompensation as adjudicated by the EAC.
时间窗: 2 years after enrollment
次要结局
- Not Applicable(None)