BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 22
- 主要终点
- Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure that uses Volt AF
研究概览
简要总结
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
- •Paroxysmal:
- •Physician's note indicating recurrent self-terminating AF AND
- •One electrocardiographically documented PAF episode within 12 months prior to enrollment.
- •Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
- •Physician's note, AND either
- •24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR
- •Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
- •That are taken at least 7 days apart but less than 12 months apart
- •If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
- •The most recent electrocardiogram must be within 180 days of enrollment.
- •NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
- •Plans to undergo a de novo ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
- •At least 18 years of age
- •Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
- •Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
排除标准
- •Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
- •Known presence of cardiac thrombus
- •Known Left ventricular ejection fraction < 35% as assessed with echocardiography within 360 days of index procedure
- •New York Heart Association (NYHA) class III or IV heart failure
- •Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
- •Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure
- •Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
- •Unstable angina
- •Stroke or TIA (transient ischemic attack) within the last 90 days
- •Heart disease in which corrective surgery is anticipated within 180 days after procedure
- •History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
- •Contraindication to long term anti-thromboembolic therapy
- •Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- •Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
- •Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
- •Previous tricuspid or mitral valve replacement or repair
- •Patients with prosthetic valves
- •Patients with a myxoma
- •Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
- •Stent, constriction, or stenosis in a pulmonary vein
- •Rheumatic heart disease
- •Hypertrophic cardiomyopathy
- •Diagnosed with amyloidosis or atrial amyloidosis
- •Active systemic infection
- •Renal failure requiring dialysis
- •Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- •Presence of an implanted LAA closure device
- •Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm
- •Unlikely to survive the protocol follow up period of 12 months
- •Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- •Individuals without legal authority
- •Individuals unable to read or write
研究组 & 干预措施
Volt PFA Catheter Sensor Enabled (SE)
Patients diagnosed with drug refractory, symptomatic, recurrent, paroxysmal and persistent atrial fibrillation that will undergo a de novo ablation procedure with the Volt PFA Catheter.
干预措施: Pulsed Field Ablation (Device)
结局指标
主要结局
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure that uses Volt AF
时间窗: 7 days
Serious adverse events are defined as: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis3 * Phrenic nerve injury resulting in permanent diaphragmatic paralysis * Pulmonary Edema * Pulmonary vein stenosis1 * Stroke * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications4 / major bleeding events5 * Device related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)
Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months.
时间窗: During procedure
Other situations in which subjects will be considered effectiveness endpoint failures include: * Cardioversion (electrical or pharmaceutical) for the treatment of AF/AFL/AT following the blanking period. * A second repeat procedure for ablation of AF recurrence within the 90-day blanking period * Any repeat ablation procedure in the left atrium (LA) for AF/AFL/AT following the 90-day blanking period * Any use of a new class I or III AAD for AF/AFL/AT after the 90-day blanking period * Any use of a class I or III AAD for AF/AFL/AT at a dose higher than the historical maximum dose for the subject after the blanking period.
Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins
时间窗: During procedure
A secondary measure of confirmation to include any one of the following (the same method must be used for all pulmonary veins) : * A minimum 20-minute wait following initial confirmation of entrance block with a second confirmation of entrance block following the 20-minute wait; or * Exit block pacing maneuvers ; or * Isoproterenol or adenosine challenge
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure that uses Volt AF
时间窗: 7 days
Serious adverse events are defined as: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis3 * Phrenic nerve injury resulting in permanent diaphragmatic paralysis * Pulmonary Edema * Pulmonary vein stenosis1 * Stroke * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications4 / major bleeding events5 * Device related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)
Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months.
时间窗: During procedure
Other situations in which subjects will be considered effectiveness endpoint failures include: * Cardioversion (electrical or pharmaceutical) for the treatment of AF/AFL/AT following the blanking period. * A second repeat procedure for ablation of AF recurrence within the 90-day blanking period * Any repeat ablation procedure in the left atrium (LA) for AF/AFL/AT following the 90-day blanking period * Any use of a new class I or III AAD for AF/AFL/AT after the 90-day blanking period * Any use of a class I or III AAD for AF/AFL/AT at a dose higher than the historical maximum dose for the subject after the blanking period.
Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins
时间窗: During procedure
A secondary measure of confirmation to include any one of the following (the same method must be used for all pulmonary veins) : * A minimum 20-minute wait following initial confirmation of entrance block with a second confirmation of entrance block following the 20-minute wait; or * Exit block pacing maneuvers ; or * Isoproterenol or adenosine challenge
次要结局
未报告次要终点