NCT07575828尚未招募不适用
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation (NEXT PULSE)
Medtronic Cardiac Ablation Solutions0 个研究点目标入组 320 人开始时间: 2026年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
研究概览
简要总结
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with the PulseSelect PFA System.
详细描述
This study will include subjects with a diagnosis of recurrent symptomatic Paroxysmal and Persistent AF. Following the index ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 2 months, 6 months, and 12 months and will be exited from the study at the conclusion of the 12-month follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law)
- •A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
- •Symptomatic paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- •Physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 12 months prior to enrollment; AND
- •at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.
- •Symptomatic persistent AF: Continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
- •Physician's note indicating at least 1 symptomatic persistent AF episode occurring within 12 months prior to enrollment; AND
- •any 24-hour continuous ECG recording documenting continuous AF within 12 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 12 months prior to enrollment
- •Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
排除标准
- •Long-standing persistent AF (continuous AF that is sustained >12 months)
- •Paroxysmal AF patients: AF that required three (3) or more distinct cardioversions in the preceding 12 months.
- •Paroxysmal AF: LA anteroposterior diameter > 5.0 cm (by MRI, CT, or TTE) Persistent AF: LA anteroposterior diameter > 5.5 cm (by MRI, CT, or TTE)
- •Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
- •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
- •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)
- •Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
- •Contraindication to or unwillingness to use systemic anticoagulation
- •Presence of any pulmonary vein stents
- •Known pre-existing pulmonary vein stenosis
- •Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
- •Moderate to severe mitral valve or aortic stenosis
- •Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
- •Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
- •Unstable angina
- •NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
- •Severe lung disease, primary pulmonary hypertension, or any lung disease abnormal blood gases or requiring supplemental oxygen
- •Rheumatic heart disease
- •Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
- •Documented left atrial thrombus on imaging
- •Active systemic infection or sepsis
- •Hypertrophic cardiomyopathy
- •Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
- •Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
- •Carotid stenting or endarterectomy
- •History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
- •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
- •Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
- •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
- •Known allergies or hypersensitivities to adhesives
- •Body mass index > 40 kg/m2
- •Atrial myxoma
- •Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- •Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant
- •Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- •Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
- •Known drug or alcohol dependency
- •Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results
- •Amyloid heart disease (cardiac amyloidosis)
研究者
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