Randomised Investigation of Physiological, Conventional and Optimised Resynchronisation Therapy in Heart Failure With Prolonged QRS Duration (RIPCORD-CRT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome: Daily ordinal symptom score with clinical over-rides
研究概览
简要总结
The goal of this clinical trial is to find out which type of specialist pacemaker-known as cardiac resynchronisation therapy (CRT)-works best for people with heart failure and a delay in how the lower chambers of the heart beat together (called electrical dyssynchrony).
The main aims of the study are:
To compare the effects of conventional biventricular pacing (BVP), conduction system pacing (CSP) and left-bundle optimised CRT (LOT-CRT) on heart failure symptoms and heart rhythm problems over six months.
To explore how these pacing methods affect heart muscle strength, electrical activity, and overall heart function.
Participants will:
Attend four hospital visits over a six-month period.
At Visit 1, meet a member of the research team to discuss the study and have screening tests to check eligibility. Participants will also have a smartphone app installed and receive training on how to record their daily heart failure symptoms.
At Visit 2, have a CRT pacemaker implanted. The type of pacemaker will be chosen at random, with a 1 in 3 chance of receiving:
- Biventricular pacing (BVP); the current standard treatment
- Conduction system pacing (CSP)
- LOT-CRT (Left-bundle optimised CRT); a combination of both
At Visit 3 (around 12 weeks after implantation) and Visit 4 (6 months after implantation), take part in routine follow-up assessments to check the pacemaker and heart function.
At Visits 2 and 4, also undergo non-invasive electrical mapping tests, including wearing a specialised vest and having a low-dose CT scan of the chest. These tests help researchers understand how the heart's electrical system responds to different pacing methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Patients referred/scheduled for a CRT procedure (new implant or upgrade) who have:
- •Symptomatic heart failure (NYHA II-IV)
- •Reduced ejection fraction (LVEF≤40%)
- •Prolonged QRS duration (≥130ms) and left bundle branch block ECG morphology or very prolonged QRS duration (>150ms) and non-left bundle branch block ECG
- •Optimal medical therapy for HF
排除标准
- •Unable to provide informed consent
- •<18 years old
- •Pregnant patients (with female patients of childbearing age requiring a negative urine BHCG)
研究组 & 干预措施
Biventricular pacing
Current standard of care cardiac resynchronisation therapy with biventricular pacing (one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus).
干预措施: Biventricular pacing (Device)
Conduction system pacing
Cardiac resynchronisation therapy with single lead targeting direct capture of the conduction system. Primary target should be left bundle area, with backup target of His bundle.
干预措施: Conduction system pacing (Device)
Left bundle optimised cardiac resynchronisation therapy (LOT-CRT)
Cardiac resynchronisation therapy delivered by conduction system optimised hybrid configurations. Primary configuration should be conduction system pacing lead targeted at the left bundle area combined with left ventricular epicardial lead accessed via the coronary sinus (LOT-CRT). Backup configuration of conduction system pacing lead targeted at the His bundle combined with left ventricular epicardial lead accessed via the coronary sinus (HOT-CRT).
干预措施: Left bundle optimised cardiac resynchronisation therapy (Device)
结局指标
主要结局
Primary outcome: Daily ordinal symptom score with clinical over-rides
时间窗: From randomisation to 6-months post device implant
Daily ordinal scale with mobile application based assessment of quality of life (using visual analogue scale), with clinical over-rides as detailed below: 1. Death 2. Intractable symptoms leading to trial exit/unblinding 3. Heart failure hospitalisation 4. Non-heart failure hospitalisation 5. Appropriate implantable cardioverter defibrillator therapy (anti-tachycardia pacing or shock, deemed appropriate as per clinical care team interrogating device) 6. Symptom score (1-600, with 1 representing minimum limitation from patient ascribed heart failure symptom and 600 representing maximum limitation)
Primary arrhythmia outcome
时间窗: From randomisation to 6-months post device implant
Ordinal arrhythmia scale using clinical endpoints as detailed below: 1. Death 2. Appropriate implantable cardioverter defibrillator therapy (anti-tachycardia pacing or shock, deemed appropriate as per clinical care team interrogating device) 3. Sustained ventricular arrhythmia (VA) (\>30s of rhythm determined to be ventricular in origin by clinical team on device interrogation) 4. Sustained atrial arrhythmia 5. Non-sustained VA 6. \>10% ventricular ectopy on 24h ECG
Primary contractility outcome
时间窗: From randomisation to 6-months post device implant
Ordinal contractility scale using clinical endpoints as detailed below: 1. Death 2. Intractable symptoms leading to trial exclusion/unblinding 3. Heart failure hospitalisation 4. Non-heart failure hospitalisation 5. Left ventricular ejection fraction (measured on transthoracic echocardiogram)
次要结局
- Rate of sustained ventricular arrhythmia(From randomisation up to 36 months)
- Rate of sustained atrial arrhythmia(From randomisation up to 36 months)
- Rate of non-sustained ventricular arrhythmia(From randomisation up to 36 months)
- Number of participants with >10% ventricular ectopy on 24h ECG(At 12-weeks post implant)
- Left ventricular ejection fraction (LVEF)(From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months))
- Left ventricular repolarisation heterogeneity(From implant to 6-months)
- QT dispersion(From randomisation to 6 months post device implant)
- Left ventricular end diastolic volume (LVEDV)(From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months))
- Left ventricular activation(From implant to 6-months)
- Left ventricular end systolic volume (LVESV)(From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months))
- Six minute walk test(From baseline to 6 months post device implantation)
- Serum B-type natriuretic peptide (BNP)(From baseline to 6 months post device implant)
- Quality of life assessed via HeartQoL questionnaire(From baseline to 6 months post device implant)
- Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)(From baseline to 6 months post device implant)
- Minnesota Living With Hearth Failure Questionnaire (MLWHFQ)(From baseline to 6 months post device implant)
- Heart failure status assessed by New York Heart Association classification(From baseline to 6 months post device implantation)
- Device derived patient activity level(At 6 months post device implant)
- Device determined atrial fibrillation burden(At 6 months post pacemaker implant)
- Rate of death(From randomisation up to 36 months, or death from any cause, whichever came first.)
- Percentage of days outside of the normal range device measured intrathoracic impedance or triggering device warning for fluid status(From implant to 6 months post pacemaker implant)
- Number of participants with intractable symptoms leading to trial exit/unblinding(From randomisation up to 36 months, or intractable symptoms leading to trial exit/unblinding, whichever came first.)
- Rate of heart failure hospitalisation(From randomisation up to 36 months)
- Rate of non-heart failure hospitalisation(From randomisation up to 36 months)
- Rate of appropriate implantable cardioverter defibrillator device therapy(From randomisation up to 36 months)
- Daily heart failure symptom score(From randomisation up to 36 months)
- Blinding index(From device implant, to 6 months post device implant)
- Number of patients with treatment related adverse events(From device implant to 36 months post device implant)