AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 480
- 试验地点
- 9
- 主要终点
- 36-Item Quality of Life (QoL)
研究概览
简要总结
A study comparing atrioventricular junction ablation (AVJA) versus continued optimum medical rate control in patients with cardiac resynchronization therapy (CRT) and atrial fibrillation (AF) with suboptimal heart rate control on optimum medication.
详细描述
Patients fulfilling the enrolment criteria will be randomly (randomization with variable blocks of 4, 6, and 8 patients) allocated to intervention and control groups in a 1:1 ratio. AVJA will be done in patients belonging to the intervention group without undue delay after the randomization. The procedure will be repeated in case of recovery of AV nodal conduction during the trial.
CRT device will be programmed to a base rate of 70 bpm, hysteresis switched off, and rate response functions activated unless not tolerated by the patient. The triggered mode will be encouraged.
All patients will be regularly followed in outpatient clinics. Cross-over to the AVJA study arm will be considered and performed at any time during the trial at the discretion of the operators. This may particularly concern patients with clinical deterioration in terms of functional status, quality of life, systolic left ventricular function, and/or repeated hospitalization, and in whom biventricular pacing (BiVP%) <<100% could be suspected as a significant underlying factor.
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
盲法说明
No masking will be used in the study
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with CRT using either a biventricular pacemaker/defibrillator or conduction system pacemaker (>6 months)
- •Diagnosis of AF and classified as: permanent AF or recurrent persistent AF, requiring emergency visits and/or hospitalizations (at least one in recent year)
- •Optimized HF medical treatment and rate control medication
- •BiVP% + ventricular premature complex (VPC%) <99% and >85% during the minimum period of 1 month while already on optimum medical therapy (applicable only for patients with permanent AF)
- •Age >18 and <85 years
- •Signed informed consent
排除标准
- •myocardial infarction (MI) or coronary artery bypass graft (CABG) <3 months
- •Technical failure of the CRT system
- •Intentional preference for spontaneous AV conduction
- •Expected survival <1 year
- •Other significant comorbidities and/or conditions that interfere with the proper conduction of the trial
- •Dementia as assessed by mini-mental test (<23 points)
研究组 & 干预措施
Atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT)
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will undergo atrioventricular junction ablation.
干预措施: Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT) (Procedure)
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will receive optimal medication treatment.
干预措施: Optimal medication treatment in patients with cardiac resynchronization therapy (CRT) (Drug)
结局指标
主要结局
36-Item Quality of Life (QoL)
时间窗: 3 years
QoL will be assessed using the 36-Item Quality of Life Questionnaire. QoL will be evaluated at 12, 24 and 36 months as a sum of points that are assigned to individual outcome measures, specifically to their change compared to the baseline. To score the SF-36, scales are standardized to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
时间窗: 3 years
MLHFQ values will be recorded and evaluated at 12, 24 and 36 months. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.
Heart failure (HF) events
时间窗: 3 years
The number of HF events will be observed.
Dose of loop diuretics
时间窗: 3 years
Change in the dose of loop diuretics will be observed and recorded. This parameter will be evaluated at 12, 24 and 36 months as an increase or decrease of the dose compared to the baseline.
NYHA classification
时间窗: 3 years
Changes in the New York Heart Association classification (NYHA) will be observed. The NYHA classification values will be evaluated at 12, 24 and 36 months. The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain.
次要结局
- All-cause death(3 years)
- Combined heart failure (HF) death and HF hospitalization(3 years)
- Time-averaged proportional change in NT-pro-Brain Natriuretic Peptide (NT-pro-BNP)(3 years)
- Death from cardiovascular diseases (CV death)(3 years)
- Days in the hospital because of heart failure (HF)(3 years)
- Time-averaged change in the NYHA class(3 years)