NL-OMON52003尚未招募不适用
Pulmonary vein isolation or atrioventricular node ablation in patients with heart failure and symptomatic atrial fibrillation diminishing CRT response (PULVERISE-AF-CRT): A randomized study - PVI vs AVN ablation: PULVERISE-AF-CRT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Presence of a cardiac resynchronization therapy device (CRT-D or CRT-P) and
- •optimal medical therapy according to current guidelines.
- •Patients with paroxysmal or persistent AF, having AF or HF related symptoms.
- •Patient with paroxysmal AF should have >25% burden or inadequate
- •biventricular pacing (<95%) based on device counters.
- •The patient is willing and able to comply with the protocol and has provided
- •written informed consent.
- •Age >= 18 years
排除标准
- •Documented left atrial diameter > 6 cm (parasternal long axis).
- •Longstanding persistent AF longer than 2 years.
- •Contraindication to chronic anticoagulation therapy or heparin
- •Previous left heart ablation procedure for AF
- •Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2
- •months prior to enrolment
- •Untreated hypothyroidism or hyperthyroidism
- •Enrolment in another investigational drug or device study.
- •Woman currently pregnant or breastfeeding or not using reliable contraceptive
- •measures during fertility age.
- •Mental or physical inability to participate in the study.
- •Listed for heart transplant.
- •Cardiac assist device implanted.
- •Planned cardiovascular intervention.
- •Life expectancy <= 12 months.
- •Uncontrolled hypertension.
- •Requirement for dialysis due to terminal renal failure.
- •Participation in another telemonitoring concept
研究者
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Continuing versus stopping heart rhythm medication after an operation restoring your normal heart rhythm in patients with a heart rhythm disorder: a study across multiple hospitals.Symptomatic persistent atrial fibrillation: atrial fibrillation, that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Episodes of atrial fibrillation have to be accompanied by symptoms.MedDRA version: 20.0Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 100000004849EUCTR2018-002103-33-DKAZ Sint-Jan Brugge-Oostende AV220
进行中（未招募）
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Continuing versus stopping heart rhythm medication after an operation restoring your normal heart rhythm in patients with a heart rhythm disorder: a study across multiple hospitals.Symptomatic persistent atrial fibrillation: atrial fibrillation, that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Episodes of atrial fibrillation have to be accompanied by symptoms.MedDRA version: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849EUCTR2018-002103-33-ESAZ Sint-Jan Brugge-Oostende AV220
进行中（未招募）
1 期
Continuing versus stopping heart rhythm medication after an operation restoring your normal heart rhythm in patients with a heart rhythm disorder: a study across multiple hospitals.Symptomatic persistent atrial fibrillation: atrial fibrillation, that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Episodes of atrial fibrillation have to be accompanied by symptoms.MedDRA version: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849EUCTR2018-002103-33-FRAZ Sint-Jan Brugge-Oostende AV220