Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 40
- 主要终点
- Effectiveness: Number of Participants With Treatment Success.
研究概览
简要总结
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.
Subjects diagnosed with symptomatic recurrent paroxysmal or persistent atrial fibrillation after a single prior ablation procedure will be enrolled in this study. Each subject will undergo a study index redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System and will be followed for 12 months. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 2 years.
详细描述
The Conquer-AF study is a prospective, multi-center, interventional, non-randomized clinical study to evaluate the safety and effectiveness of the Sphere-9 Catheter and Affera Ablation System, when used in conjunction with the Affera Mapping System or Affera Integrated Mapping System, in patients undergoing redo ablation for symptomatic recurrent paroxysmal or persistent atrial fibrillation following a single prior ablation procedure.
This study will enroll up to 400 subjects diagnosed with symptomatic recurrent PAF and PsAF and will be conducted at up to 30 study sites located across the United States, Europe, and Australia. No single site may enroll more than 60 (with no more than 37 in either cohort) subjects to ensure a reasonable distribution of subjects across sites.
Adult subjects with symptomatic recurrent PAF and PsAF will undergo a study index redo ablation procedure with the Sphere-9 Catheter and Affera Ablation System. Following the study index redo ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 3 months, 6 months, and 12 months post-procedure. Subjects will be exited from the study at the conclusion of the 12-month follow-up visit and associated 24-hour Holter. The expected total study duration is approximately 2 years, representing approximately 12 months of enrollment and 12 months of subject follow-up. Treated subjects will not be replaced with newly enrolled subjects upon early study exit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. History of a single AF ablation procedure for PAF or PsAF within 3 years prior to enrollment
- •Documented evidence of symptomatic AF, AT or AFL recurrence at least 90 days after subject's de novo ablation procedure, as demonstrated by:
- •A physicians' note indicating at least 1 symptomatic AF, AT, or AFL episode occurring within 12 months prior to the enrollment; and
- •At least 1 electrocardiographically documented episode of AF, AT, or AFL within 12 months prior to enrollment
- •Adults who are ≥18 years of age on the day of enrollment
- •Willing and able to comply with all study requirements and provide informed consent
排除标准
- •1. Continuous AF lasting for 12 months or longer
- •LA anteroposterior >55 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume >100 mL for PsAF subjects; OR LA anteroposterior >50 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume >95 mL for PAF subjects
- •Previous left atrial percutaneous interventions including left atrial appendage occlusion and septal closure devices
- •Planned left atrial appendage (LAA) closure procedure, cardiac transplantation 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
- •More than 1 previous AF ablation procedure
- •Any prior surgical ablation procedure
- •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
- •Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
- •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)
- •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, or 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 within the 3 months preceding the consent date
- •NYHA Class III or IV congestive heart failure
- •Documented left ventricular ejection fraction (LVEF) ≤40%, measured by acceptable cardiac testing (e.g., TTE)
- •Unstable angina
- •Severe lung disease, primary pulmonary hypertension, or any lung disease requiring supplemental oxygen
- •Rheumatic heart disease
- •Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
- •Presence of left atrial thrombus on imaging
- •Active systemic infection or sepsis
- •Hypertrophic cardiomyopathy
- •Amyloid heart disease
- •Diagnosed atrial myxoma
- •Known reversible causes of AF (e.g., uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, acute alcohol toxicity or other reversible or non-cardiac cause)
- •Any cerebral ischemic event (strokes or TIAs) which occurred within the preceding 6 months of the consent date through the date of study index redo ablation procedure
- •Carotid stenting or endarterectomy
- •Thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
- •Body mass index > 40 kg/m2
- •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 study of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- •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
- •Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
- •Presence of an inferior vena cava (IVC) filter (e.g., Greenfield or similar) that would preclude safe transfemoral venous access, catheter passage, or sheath manipulation.
- •40. Known drug or alcohol dependency
- •Significant congenital anomaly or medical problem that would, in the opinion of the investigator, preclude enrollment, follow-up compliance, or the scientific integrity of the study
- •*Women who are of child-bearing potential must undergo a pregnancy test after consent and prior to the study index redo ablation procedure, as allowed according to local regulations
研究组 & 干预措施
Single Arm: Redo AF Ablation with Sphere-9 Catheter
Participants undergo a redo atrial fibrillation ablation using the Sphere-9 Catheter and the Affera Ablation System per study protocol. All subjects receive the same intervention with no control or comparator arm.
干预措施: Sphere-9 Catheter Ablation (Device)
结局指标
主要结局
Effectiveness: Number of Participants With Treatment Success.
时间窗: 12-months post-redo ablation procedure
Treatment success is defined to be freedom from treatment failure. The study requires 24-hour Holter monitoring at 6 and 12 months, weekly and symptomatic patient activated TTM transmissions through 12 months, and 12-lead ECGs or TTMs at all follow up visits. Treatment failure is defined as any of the following components: * Inability to successfully complete the study index redo ablation procedure utilizing the Sphere-9 Catheter and Affera Ablation System exclusively * Documented AF/AT/AFL after the 90-day post-ablation blanking period * Any subsequent catheter or surgical ablation, for recurrent AF/AT/AFL including repeat redo ablation at any time during the study * Direct current or pharmacological cardioversion for AF/AT/AFL recurrences after the 90-day blanking period (See section 9.11) * Use of a Class I or III AAD at a higher daily dose than the pre-ablation maximum dose after the 90-day blanking period and on or before day 365. * Initiation of a new Class I or III AAD after t
Safety: Number of Participants With at Least One Primary Safety Event
时间窗: 6-months post-redo ablation procedure
Primary safety events include: * 7 days of post-ablation: AKI requiring dialysis, new hospitalization \>48 hours, or prolongation of hospitalization \>48 hours beyond expected discharge, Death, Heart block requiring pacemaker, Major bleeding requiring transfusion, MI, Permanent phrenic nerve paralysis, Pulmonary edema, Severe pericarditis, Significant pericardial effusion/tamponade, Stroke/CVA, Systemic/pulmonary embolism requiring intervention, TIA, Vagal nerve injury resulting in esophageal dysmotility or gastroparesis, Vascular access complications requiring intervention, Any Sphere-9 Catheter or Affera Mapping \& Ablation System device- or procedure-related cardiovascular and/or pulmonary AE that prolongs or requires hospitalization \>48 hours (excl recurrent AF/AT/AFL) * 3 months post-ablation: Atrioesophageal fistula/esophago-pericardial fistula, Esophageal perforation (procedure \& Sphere-9 Catheter related) * 6 months post-ablation: Pulmonary vein stenosis (≥70% diameter reduction)
次要结局
未报告次要终点