NCT07789925尚未招募不适用
Treatment of Paroxysmal Atrial Fibrillation With the Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System in China
Medtronic Cardiac Ablation Solutions10 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年9月2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
- 180
- 试验地点
- 10
- 主要终点
- Primary safety endpoint: Freedom from Device- and/or Procedure-Related Serious Adverse Events Through 6 Months Post-Ablation
研究概览
简要总结
The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have not been helped by, cannot tolerate, or cannot take certain medicines for PAF.
The main questions it aims to answer are:
Is the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System safe for treating PAF? Does the treatment help keep patients free from atrial fibrillation and other abnormal heart rhythms during the 12 months after the procedure?
Participants will:
Have their heart rhythm assessed before and after the ablation procedure. Have PAF treated using the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System.
Have follow-up visits at 3, 6, and 12 months after the procedure.
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
- •Failure of, intolerance to, or contraindication to at least one Class I-IV AAD for the treatment of PAF, as evidenced by recurrent symptomatic AF. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- •a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
- •at least 1 electrocardiographically documented episode within 12 months prior to enrollment
- •Adults who are ≥18 and ≤80 years of age on the day of enrollment.
- •Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
排除标准
- •Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration > 7 days
- •AF that required three (3) or more distinct cardioversions in the preceding 12 months.
- •LA anteroposterior > 5.0 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
- •Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
- •Presence of a permanent pacemaker, biventricular pacemaker, , or any type of implantable cardiac defibrillator (with or without biventricular pacing function), , or presence of a loop recorder or insertable cardiac monitor (ICM) that has not reached manufacturer-defined end of service (or equivalent end-of-life state)
- •Presence of any pulmonary vein stents
- •Known pre-existing pulmonary vein stenosis
- •Pre-existing hemidiaphragmatic paralysis
- •Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
- •Moderate to severe aortic or mitral valve 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 with abnormal blood gases or requiring supplemental oxygen
- •Rheumatic heart disease
- •Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
- •Contraindication to or unwillingness to use systemic anticoagulation
- •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.
- •Treatment with Amiodarone within the 3 months prior to enrollment
- •Amyloid heart disease (cardiac amyloidosis)
结局指标
主要结局
Primary safety endpoint: Freedom from Device- and/or Procedure-Related Serious Adverse Events Through 6 Months Post-Ablation
时间窗: Through 6 months post-ablation
The proportion of participants who are free from device- and/or procedure-related serious adverse events through 6 months after the ablation procedure.
Primary effectiveness endpoint: Treatment Success at 12 Months Post-Ablation
时间窗: 12 months post-ablation
The proportion of participants achieving treatment success (freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data) at 12 months after the ablation procedure and excluding a 90-day blanking period.
次要结局
- Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaires score from baseline through 12 months after the index ablation procedure(Baseline through 12 months after the index ablation)
- Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) composite score from baseline through 12 months after the index ablation procedure(Baseline through 12 months after the index ablation procedure)
研究者
研究点 (10)
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