JPRN-jRCT2052210035已完成3 期
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF)
Shiomitsu Aki0 个研究点目标入组 400 人开始时间: 2021年6月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
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
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
- •2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
- •a. Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- •1) Physicians note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and
- •2) at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment
- •b. Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
- •1) physicians note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment; and
- •2) any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment;
- •2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment
- •3. Age 18 through 80 years old (or older than 18 if required by local law)
排除标准
- •1.Long-standing persistent AF (continuous AF that is sustained >12 months)
- •2.Left atrial diameter > 5.0 cm (anteroposterior)
- •3.Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
- •4.Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
- •5.Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
- •6.Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- •7.Presence of any pulmonary vein stents
- •8.Presence of any pre-existing pulmonary vein stenosis
- •9.Pre-existing hemidiaphragmatic paralysis
- •10.Presence of any cardiac valve prosthesis
- •11.Moderate to severe mitral valve stenosis
- •12.More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
- •13.Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
- •14.Unstable angina
- •15.NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. TTE)
- •16.Primary pulmonary hypertension
- •17.Rheumatic heart disease
- •18.Thrombocytosis, thrombocytopenia
- •19.Any condition contraindicating chronic anticoagulation
- •20.Active systemic infection
- •21.Hypertrophic cardiomyopathy
- •22.Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
- •23.Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
- •24.History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
- •25.Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
- •26.Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
- •27.Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- •28.Known allergies or hypersensitivities to adhesives
- •29.Unwilling or unable to comply fully with study procedures and follow-up
- •30.Unable to provide own informed consent
研究者
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