Danish Randomized Trial on VDD Leadless Atrial Tracking With MicraTM AV Transcatheter Pacing System vs Transvenous DDD Pacing in Elderly Patients With AV-block
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Quality of Life by SF36
研究概览
简要总结
The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.
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 (Investigator, Outcomes Assessor)
盲法说明
Partly patient and accessor blinded and partly open label.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time pacemaker implantation on class I or II ESC recommendations for AVB with an expected amount of right ventricular pacing >80% of the time,
- •Age 75 years or older
- •Intact sinus node function
- •Expected survival more than 12 months based on clinical evaluation
- •Able to provide informed consent
排除标准
- •Persistent or previous cardiac implantable electronic device i.e., pacemaker, ICD, or CRT.
- •Persistent, or chronic atrial fibrillation
- •Reversible AVB
- •Transient AVB due to ongoing ischemia
- •Heart failure NYHA class III-IV
- •Heart failure with branch block and indication for CRT implantation, irrespective of NYHA class
- •Indication for primary or secondary prophylactic ICD implantation
- •Acute myocardial infarction (AMI) within 3 months
- •Severe chronic pulmonary disease with pulmonal hypertension limiting exercise capacity
- •Expected survival < 12 months based on clinical evaluation
- •Performing high intensity sport
- •Participation in another trial with experimental treatment
- •Contraindication against device implantation (e.g., concurrent infection)
- •Failure to provide informed consent
研究组 & 干预措施
Leadless Pacemaker
Implantation with a leadless pacemaker
干预措施: Leadless Micra AV Transcatheter Pacing System (Device)
Transvenous pacemaker
Implantation with a transvenous pacemaker
干预措施: Transvenous Azure XT DR dual chamber pacemaker (Device)
结局指标
主要结局
Quality of Life by SF36
时间窗: 7 months
Self-reported health-related quality of life as measured by Short-Form 36 quality of life questionnaire. The scale ranges from 0 to 100. 0 denotes minimal quality of life and 100 denotes maximum quality of life.
次要结局
- Exercise capacity by 6MWT(7 months)
- Patient Acceptance by FPAS(7 months)