Complex Fractionated Atrial Electrocardiograms (CFAEs) Spatiotemporal Dispersion Guided Ablation Versus Pulmonary Vein Isolation (PVI) Guided Ablation in Persistent Atrial Fibrillation, a Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia (>30 seconds) recurrences without the use of class I or III AADs
研究概览
简要总结
Objective: The purpose of this study is to compare the efficacy and safety of ablation of Atrial Fibrillation (AF) drivers marked by spatiotemporal dispersions and Complex Fractionated Atrial Electrocardiograms (CFAEs) to Pulmonary Vein Isolation (PVI) based ablation in patients with persistent AF.
Hypothesis: CFAE/spatiotemporal dispersion guided ablation will increase AF free survival compared to a PVI guided ablation.
Patient population: Patients with persistent AF will be randomized based on a 2:1 ratio into one of two study arms:
- CFAE/spatiotemporal dispersion guided ablation: CFAE mapping and ablation during AF aimed at restoring sinus rhythm during ablation.
- PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals
详细描述
Design: A prospective, multicenter, randomized unblinded clinical study.
Objective: The purpose of this study is to compare the efficacy and safety of ablation of AF drivers marked by spatiotemporal dispersions and CFAEs guided ablation to PVI guided ablation in patients with persistent AF.
Hypothesis: CFAE/spatiotemporal dispersion guided ablation will increase AF free survival compared to a PVI guided ablation.
Enrollment: 180 patients will be enrolled in this study.
Clinical Sites: International (including non EU-countries), multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients with persistent atrial fibrillation, defined as atrial fibrillation which is:
- •Sustained beyond 7 days but no more than one year.
- •Or lasting less than 7 days, but longer than 48 hours and necessitating pharmacologic or electrical cardioversion.
- •Documentation of atrial fibrillation on either a 12-lead ECG or transtelephonic monitoring (TTM), or ambulatory holter monitoring or telemetry strip and a physician's note showing continuous AF.
- •Failure of at least one AAD (Class I or III) as evidenced by recurrent symptomatic AF or intolerable side effects of the AAD.
- •Signed Patient Informed Consent Form.
- •Age 18 years or older.
- •Able and willing to comply with all pre- and follow-up testing and requirements.
排除标准
- •Continuous AF > 12 months (1-Year) (Longstanding Persistent AF).
- •Previous surgical or catheter ablation for atrial fibrillation.
- •Any cardiac surgery within the past 2 months (60 days) (includes PCI).
- •CABG surgery within the past 6 months (180 days).
- •Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- •Cardioversion refractory (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion).
- •If a patient does not have documented evidence of being successfully cardioverted (NSR > 30 secs), the patient must be cardioverted prior to the ablation procedure with the study catheter.
- •Failure to cardiovert based on the above criteria is considered a screen failure.
- •Documented LA thrombus on imaging.
- •LA size >50 mm.
- •LVEF < 30%.
- •Contraindication to anticoagulation (heparin or warfarin).
- •History of blood clotting or bleeding abnormalities.
- •Myocardial infarction within the past 2 months (60 days).
- •Documented thromboembolic event (including TIA) within the past 12 months (365 days).
- •Rheumatic Heart Disease.
- •Uncontrolled heart failure or NYHA function class III or IV.
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days).
- •Unstable angina.
- •Acute illness or active systemic infection or sepsis.
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •Diagnosed atrial myxoma.
- •Presence of implanted ICD.
- •Significant severe pulmonary disease, (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- •Women who are pregnant (as evidenced by pregnancy test if pre- menopausal).
- •Enrollment in an investigational study evaluating another device, biologic, or drug.
- •Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
- •Presence of a condition that precludes vascular access.
- •Life expectancy or other disease processes likely to limit survival to less than 12 months.
结局指标
主要结局
Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia (>30 seconds) recurrences without the use of class I or III AADs
时间窗: 18 months
Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (\>30 seconds) without the use of class I or III AADs through 18 months follow-up, post blanking period after ablation on either a 12 lead ECG on visits or on 24 hour holter monitoring or on symptom-driven event monitoring
次要结局
- Number of redo-procedures(18 months)
- Total time of fluoroscopy(1 day)
- Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (>30 seconds) regardless of antiarrhythmic drugs(18 months)
- Symptoms associated with atrial arrhythmias(18 months)
- Quality of life at 6 and 12 months compared to baseline(6 months and 12 months)
- Decreased anti-arrhythmic and/or anticoagulant drug use.(18 months)
- Total procedure time(1 day)
- Freedom from recorded atrial fibrillation (>30 seconds), regardless of antiarrhythmic drugs(18 months)
- Clinical/partial success at 18 months regardless of antiarrhythmic drug use(18 months)
- Freedom from recorded atrial fibrillation or atrial flutter recurrences (>30 seconds) regardless of antiarrhythmic drugs(18 months)
- Time to first symptomatic, recorded AF recurrence(18 months)
- Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (>30 seconds), without a new AAD or a previously failed AAD at a greater than the highest ineffective historical dose(18 months)
- Time to first electrocardioversion(18 months)
- Total ablation time(1 day)
- The combined endpoint consisting of: Mortality and Hospitalization(18 months)
- Clinical adverse events(18 months)