Physiological Pacemaker Treatment in Combination With AV Node Ablation Compared With Pulmonary Vein Isolation for Patients With Symptomatic Atrial Fibrillation - a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Health related Quality of Life: questionnaire
研究概览
简要总结
Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least moderately dilated left atrium.
Patient population:
90 patients aged 70-85 years with atrial fibrillation, referred to either AV node ablation or pulmonary vein isolation.
Primary endpoint:
Improvement in health-related quality of life as measured by the physical component summary (PCS) of the well-validated SF-36 form, at one year after AV node ablation + CSP or AF ablation.
Secondary endpoints:
Physical performance measured by 6-minute walk test, biochemical markers of heart failure (NT-ProBNP), frequency of complications, left ventricular systolic and diastolic function, and left atrial size evaluated after 12 months. Arrhythmia specific symptoms and anxiety will be measured with the ASTA and HADS questionnaires. Arrhythmia symptom correlation between subjective and objective findings. After three years, clinical endpoints will be evaluated regarding overall survival, and risk of heart failure hospitalization or death. The cost of the treatments will be compared, and estimated cost per quality adjusted year of life will be calculated, based on the EQ5D questionnaire.
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
- None
入排标准
- 年龄范围
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for invasive treatment of symptomatic atrial fibrillation according to current guidelines
- •LVEF >35%
- •Age 70-85 years
- •Persistent atrial fibrillation, or paroxysmal atrial fibrillation with at least moderate enlargement of the left atrium (≥42ml/m2)
- •Chronic and well-tolerated treatment with anticoagulants (either non-vitamin K oral anticoagulant or vitamin K antagonist)
- •Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent
排除标准
- •Chronic atrial fibrillation with >1 year duration
- •BMI >40kg/m2
- •Hypertrophic cardiomyopathy
- •Severe heart failure with symptoms ≥ NYHA class IIIb
- •Heart amyloidosis
- •Cardiac sarcoidosis
- •Recent (<3 months) myocardial infarction
- •Significant heart valve disease (pronounced insufficiency or stenosis)
- •Pacemaker or ICD treatment ongoing, or current pacemaker indication
- •Congenital heart disease that required surgical correction
- •Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival
研究组 & 干预措施
Conduction System pacing plus AV node ablation
A His-pacing lead in combination with a backup RV pacing lead or an LBB pacing lead, and a right atrial lead (if needed) will be placed using standard technique. The His-pacing or LBB pacing lead will be Medtronic 3830, and the outer sheath will be either Medtronic C304 or C315 deflectable. If failure to implant with these tools, other leads and sheaths can be used at the discretion of the operator. A standard DDD pacemaker or CRT-P device from Medtronic will be used.
A minimum of three weeks post-implant, the device will be interrogated and His-bundle threshold will be evaluated. A threshold of ≤2.0V@1.0ms is acceptable. If the device is well-functioning and successful His-pacing is documented, AV node ablation will be performed.
干预措施: Conduction System pacing and AV node ablation (Procedure)
Pulmonary vein isolation
Atrial fibrillation will be performed as a complete pulmonary vein isolation. Either Cryoballon or radio frequency ablation with irrigated tip contact force enabled catheter can be used. Pulsed field ablation can be used if available. Endpoint is complete electrical isolation of all pulmonary veins, verified by entry- and exit block using a multipolar catheter during pacing.
干预措施: Atrial fibrillation ablation by pulmonary vein isolation (Procedure)
结局指标
主要结局
Health related Quality of Life: questionnaire
时间窗: 12 months
Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire
次要结局
- Physical performance(12 months)
- Safety endpoint: Proportion of patients with major adverse events(12 months)
- Mental Quality of Life: questionnaire(12 months)
- Hospitalization for heart failure(3 years)
- Arrhythmia related Quality of Life: ASTA questionnaire(12 months)
- Anxiety and depression(12 months)
- Ejection fraction(12 months)
- Biomarker for heart failure(12 months)
- Health economy(12 months)
- Survival(3 years)
- Electrocardiography changes(12 months)