ABLATE 与 PACE：PVI 或 AV 结消融和 PM 植入治疗老年持续性房颤患者
老年持续性心房颤动患者肺静脉隔离或房室结消融和起搏器植入术（ABLATE 与 PACE）
As patients age, symptom control and treatment of atrial fibrillation become equally difficult, often leading to increased hospitalization. ABLATE versus PACE is a prospective, randomized clinical trial comparing pacemaker implantation with AV node ablation with pulmonary vein isolation in terms of rehospitalization and quality of life in patients with persistent AF aged 75 years and older.
研究概览
地位
条件
详细说明
Atrial fibrillation is the most common cardiac arrhythmia and is a major public and represents a major public health problem with increasing healthcare costs and increased mortality risk.
In case of recurrent symptomatic atrial fibrillation current guidelines recommend pulmonary-vein isolation (PVI) as invasive treatment option. However, 5-year arrhythmia-free survival estimate is 29% after single catheter ablation. Although the long-term success rates in maintaining sinus rhythm are higher than with drug-based rhythm control, they are still moderate, especially in older patients with comorbidities. Therefore, repeated interventions are often necessary.
An effective method for frequency control is atrioventricular (AV) node ablation after implantation of a pacemaker ("ablate-and-pace"). In this case, the ventricular rate is only set by the pacemaker and can be programmed according to the patient's needs.
There are some theoretical disadvantages of this treatment option (pacemaker dependency, reduction of cardiac outpout due to lack of atrial contraction) which is why this method nowadays is almost exclusively used in older (and physically less active) patients.
The ABLATE versus PACE trial is a prospective randomized clinical trial comparing at 196 these two treatment options in terms of rehospitalizations due to cardiovascular causes and quality of life in elderly patients (≥ 75 years) with normal ejection fraction (≥ 50%).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Innsbruck、奥地利
- Universitätsklinikum Innsbruck
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Bad Nauheim、德国
- Kerckhoff-Klinik Bad Nauheim
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Berlin、德国
- Vivantes Klinikum am Urban
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Essen、德国
- Universitätsklinikum Essen
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Frankfurt、德国
- Universitätsklinikum Frankfurt am Main
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Fürth、德国
- Klinikum Fürth
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Hagen、德国
- Ev. Krankenhaus Hagen-Haspe
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Hamburg、德国
- Asklepios Klinik St. Georg
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Kaiserslautern、德国
- Westpfalz-Klinikum Kaiserslautern
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Landshut、德国
- Krankenhaus Landshut-Achdorf
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Münster、德国
- Universitätsklinikum Münster
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Wiesbaden、德国、65189
- St. Josefs-Hospital Wiesbaden GmbH
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Persistent AF according to current ESC guideline (2020)
- Symptoms EHRA classification II - IV despite guideline indicated medical therapy
- Age ≥ 75 years
- Capability of giving written informed consent
Exclusion Criteria:
- impaired systolic left ventricular function (ejection fraction < 50%)
- High-grade (III°) left cardiac valvular disease
- pre-implanted pacemaker
- bradycardia-indication for pacemaker
- Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI
- contraindication for PVI or pacemaker-implantation
- contraindication for oral anticoagulation
- body-mass-index BMI > 40 kg/m2
- inability to give written informed consent
- concomitant participation in another registered trial
- life expectancy < 12 months
- reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：冷冻球肺静脉隔离
|
Electrical isolation of the pulmonary-veins using cryoenergy |
|
有源比较器：房室结消融和起搏器植入
|
Pacemaker implantation and ablation of atrioventricular-node |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
空白期后房颤、房性心动过速或扑动症状复发需要重复消融、电复律或药物复律的受试者人数
大体时间：36个月
|
36个月
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“消融起搏”组因左心室收缩功能下降且射血分数≤35%而需要升级至心脏再同步化治疗起搏器的受试者人数
大体时间：36个月
|
36个月
|
|
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Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment
大体时间：36 months
|
except for protocol-indicated AVN ablation |
36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
因任何原因死亡
大体时间：36个月
|
36个月
|
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患有非致命性或致命性中风/短暂性脑缺血发作 (TIA) 的受试者人数
大体时间：36个月
|
36个月
|
|
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左室收缩功能恶化≥10%
大体时间：36个月
|
36个月
|
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需要重复消融的受试者数量
大体时间：36个月
|
36个月
|
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初始消融后需要抗心律失常药物治疗的受试者人数
大体时间：36个月
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36个月
|
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因发生主要或次要终点而住院的天数
大体时间：36个月
|
36个月
|
|
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Number of subjects with procedure-associated complications
大体时间：36 months
|
(major bleeding by Bleeding Academic Research Consortium Definition (BARC ≥ 2) criteria, major groin site complications prolonging inpatient stay, pacemaker pocket bleeding prolonging inpatient stay, pericardial effusion, cerebrovascular or systemic embolism, phrenic nerve palsy, lead dislodgment, lead perforation, infection including pacemaker pocket infection, lead infection / pacemaker related endocarditis) |
36 months
|
|
Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)
大体时间：36 months
|
Scale 20-140 with higher score indicating worse quality-of-life. |
36 months
|
合作者和调查者
调查人员
- 首席研究员：Joachim Ehrlich, MD、St. Josefs-Hospital Wiesbaden GmbH
- 首席研究员：Andreas Boehmer, MD、St. Josefs-Hospital Wiesbaden GmbH
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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