NCT07385417招募中不适用
Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
Cardioangiologisches Centrum Bethanien1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年4月12日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
The proposed pilot study is a prospective, randomized, single-center feasibility study, enrolling 200 patients with symptomatic paroxysmal AF. Per protocol, 100 patients will undergo a FARAPULSE electroporation PVI and 100 patients will receive standard AF medical treatment.
Prior enrollment, all patients will be informed on the risk and benefits of the PVI procedure as well as the medical treatment. In addition, particular information on the rationale of the study, including a detailed risk/benefit analysis, will be provided to all patients.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seeking emergency (E) treatment including emergency room (ER) presentation
- •Paroxysmal AF diagnosed according to current ESC guidelines
- •Diagnosis of HFpEF according to ESC guidelines 2021 (clinical symptoms, EF>50%, objective evidence of functional abnormality: LV diastolic dysfunction, NT-proBNP (non acute setting): sinus rhythm: 125pg/ml or AF: 365pg/ml, vs. acute HF: >450 pg/ml if aged <55 years, >900 pg/ml if aged between 55 and 75 years and >1800 pg/ml if >75ys.
- •Age between 18 and 80 years
- •Left atrial size, LA < 55mm
- •Left ventricular ejection fraction, EF >50%
- •Patients able to provide informed consent and willing to comply with all pre-, post- and follow up requirements as per study protocol -
排除标准
- •Currently participating in an interventional (drug, device, biologic, etc.) clinical trial
- •Any disease that limits life expectancy to less than one year
- •Contraindications for PVI
- •Contraindication for AAD therapy
- •Active systemic infection
- •Thrombocytosis, thrombocytopenia
- •Known pre-existing hemi-diaphragmatic paralysis
- •Any untreated or uncontrolled hyperthyroidism or hypothyroidism
- •Reduced immune function or otherwise at high risk for infection per physician discretion
- •Active malignancy or history of chemotherapy or radiation treatment
- •Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
- •Any cardiac surgery, myocardial infarction, PCI/PTCA or coronary artery stenting which occurred within the 3 months before the eligibility assessment
- •Instable angina pectoris
- •Primary pulmonary hypertension
- •Any condition contraindicating chronic anticoagulation
- •Any cerebral ischemic event (strokes or TIAs) which occurred within the 3 months before the consent date
- •Presence of any cardiac prosthetic valves
- •Left atrial diameter > 55 mm (anteroposterior) by TTE
- •Presence of any pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis (identified by CT or MRI and defined as at least 70% reduction of the PV diameter)
- •Endocarditis, pericarditis or pericardial effusion
- •Pregnant or breastfeeding women or women of childbearing potential not on adequate birth control.
- •Substance abuse
- •Unwilling to follow the study protocol and to attend follow-up visits
研究组 & 干预措施
AF Ablation with electroporation
Active Comparator
Patient in this arm will receive AF-Ablation
干预措施: AF Ablation (Procedure)
best medical AF treatment including rhythm and rate control (n=100)
No Intervention
In this group patients reeive anti arrhythmia medication or ECV
结局指标
主要结局
Primary Endpoint
时间窗: within the study duration of 1 Year
composite of cardiovascular hospitalization, death, systemic embolism, stroke and emergency (E) treatment for cardiovascular reason.
次要结局
- Secondary Endpoint(Within one year study)
研究者
研究点 (1)
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