CRT Improved Clinical Response UK Trial: A Multi-centre, Prospective, Randomized, Cross-over, Double Blind Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Left ventricular end-systolic volume (LVSV)
研究概览
简要总结
The main objective of the CRICKET study is demonstrate that AV and VV optimization using SonR improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS) after 6 months of treatment. In this investigator-initiated, multi-centre, 2:2 factorial design, randomized, two-arm, double-blinded, cross-over, prospective trial, CRT recipients will be randomized to 'SonR' atrioventricular (AV) and ventricular-ventricular (VV) optimization or 'fixed settings'. The primary endpoint is an absolute reduction in left ventricular end-systolic volume.
详细描述
This is an investigator-initiated, multi-centre, 2:2 factorial design, randomized, two-arm, double-blinded, cross-over, prospective trial
Main study objectives
The main objective of the CRICKET study is demonstrate that AV and VV optimization using SonR improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS) after 6 months of treatment.
Study endpoints
Primary endpoint: The primary endpoint is a reduction (absolute difference) in LVESV with SonR vs FS after 6 months of treatment. The difference intra-patient of absolute change of LVESV value will be compared between two treatments: "SonR optimization" vs. "FS", defined as a sensed AV delay of 125 ms, VV delay of 0 ms (simultaneous).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for implantation of a CRT-D device according to current NICE or ESC guidelines;
- •In sinus rhythm;
- •NYHA class II, III or IV
- •Have reviewed, signed and dated an informed consent
排除标准
- •Inability to do a 6 min walk test.
- •Previous implant with a pacemaker, an ICD or a CRT device (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance);
- •Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
- •Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
- •Incessant ventricular tachyarrhythmia;
- •Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks;
- •Correctable valvular disease that is the primary cause of heart failure;
- •Indication for valve repair or replacement;
- •Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months);
- •On transplant waiting list;
- •Previous heart transplant;
- •Already included in another clinical study that could confound the results of this study;
- •Life expectancy less than 1 year;
- •Inability to understand the purpose of the study;
- •Unavailability for scheduled follow-up or refusal to cooperate;
- •Age of less than 18 years;
- •Pregnancy;
- •Drug addiction or abuse;
- •Under guardianship.
结局指标
主要结局
Left ventricular end-systolic volume (LVSV)
时间窗: 6 months
Reduction in LVESV with SonR vs FS after 6 months of treatment
次要结局
- Quality of life - general (non-disease specific)(6 months)
- Disease-specific quality of life (heart failure)(6 months)
- System safety assessed by Adverse Events(6 months)
- Left ventricular ejection fraction(6 months)
- AF burden(6 months)
- Patient global assessment(6 months)
- Walking distance on 6 -minute walk test(6 months)
- NYHA class(6 months)