Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 13
- 主要终点
- 6-minute walk test
研究概览
简要总结
The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.
详细描述
This study will be the first to bring evidence on CRT efficacy in ACHD patients with heart failure and SRV. If results are positives, CRT may improve functional capacities and quality of life of patients and will become an option of choice in this population. If results are negatives, futile CRT implantation may be avoided in this population in particular considering potential adverse effects and CRT-related complications.
Double blind randomized cross-over trial. 40 patients will be enroled. Their follow-up will be 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •systemic right ventricle (SRV),
- •CRT-P or CRT-D device implanted for at least 1 month,
- •Age ≥18 years old,
- •One of the two following CRT indications:
- •NYHA II-IV, right ventricular ejection fraction ≤ 35% and spontaneous QRS duration ≥ 150 ms Or
- •NYHAI-IV, atrioventricular conduction disorders with ventricular pacing > 40% (regardless right ventricular ejection fraction).
- •Affiliation to a french social security system (beneficiary or legal)
- •Informed and signed consent
排除标准
- •Pregnancy or breastfeeding
- •Women of childbearing potential who do not have a negative pregnancy test and do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion
- •Patient benefiting from a measure of legal protection (guardianship, curatorship, under judicial safeguard, activated future protection mandate and family authorization),
- •Cardiac surgery during the last 3 months or planned during the next 6 months,
- •Percutaneous structural cardiac intervention planned during the next 6 months,
- •Persistent atrial arrhythmia with catheter ablation planned during the next 6 months,
- •Acute congestive heart failure,
- •Dysfunction of at least one CRT device lead that compromise biventricular pacing,
- •Patient on AME
- •Current participation in another interventional clinical study or being in the exclusion period at the end of a previous study.
研究组 & 干预措施
CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)
Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in "CRT ON" then "CRT OFF" mode.
干预措施: CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing) (Device)
CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in "CRT OFF" then "CRT ON" mode.
干预措施: CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing) (Device)
结局指标
主要结局
6-minute walk test
时间窗: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
The 6-minute walk test will be performed by a trained technician, indoors, along a long, flat, straight, enclosed corridor with a hard surface and a minimal length of 30 meters. The length of the corridor will be marked every 3 meters and the turnaround points will be marked with a cone. The starting line will be marked on the floor using brightly colored tape. Specific and standardized instructions will be transmitted to the patient.
次要结局
- Diuretics(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- Tricuspid valve regurgitation(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- NYHA classification(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- Peak oxygen uptake(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- Right ventricular ejection fraction(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- Premature cross-over phase termination(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- Ventricular arrhythmias(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- BNP(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- QRS duration(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- Quality of life of patients(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))
- Heart failure(Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months))