Pulmonary Vein Isolation Versus Complex Procedure Using Pulsed-field Ablation in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Atrial fibrillation recurrence
研究概览
简要总结
Since a new method called pulsed-field ablation (PFA) has emerged, allowing significantly simpler, safer, and faster creation of ablative lesions in paroxysmal AF and PsAF (13), redefining the "optimal" ablation approach started to appear mandatory. Our project (The PIVCO study) aims to determine a more standardized procedure representing optimal ablation strategy for patients suffering from PsAF using PFA and multielectrode ablation catheters. The central hypothesis is that ablation of the posterior LA wall (PWI), together with mitral and cavotricuspid isthmus ablation added on top of PVI, will be associated with better effects in terms of rhythm control. Given the speed, safety, and ease of standardization of ablation using electroporation, a demonstration of the superiority of either approach could significantly impact the current standard of clinical care.
详细描述
Purpose Since a new method called pulsed-field ablation (PFA) has emerged, allowing significantly simpler, safer, and faster creation of ablative lesions in paroxysmal AF and PsAF (13), redefining the "optimal" ablation approach started to appear mandatory. Our project (The PIVCO study) aims to determine a more standardized procedure representing optimal ablation strategy for patients suffering from PsAF using PFA and multielectrode ablation catheters. The central hypothesis is that ablation of the posterior LA wall (PWI), together with mitral and cavotricuspid isthmus ablation added on top of PVI, will be associated with better effects in terms of rhythm control. Given the speed, safety, and ease of standardization of ablation using electroporation, a demonstration of the superiority of either approach could significantly impact the current standard of clinical care.
Primary endpoints
(1) The primary endpoint will be a recurrence of AF (or atrial tachycardia, AT) lasting >30 seconds as assessed using repeated 7-day ECG Holter monitoring in patients without anti-arrhythmic drugs (AADs) during the entire post-blanking follow-up, i.e., starting three months after the index procedure. All patients should complete a 12-month follow-up period.
Secondary endpoints
(1) The first recurrence of on-AADs AF/AT lasting >6 minutes during the post-blanking follow-up period (i.e., disregarding all off-AAD episodes). (2) Number of hospitalizations and emergency out-patient visits related to AF/AT recurrence, worsening of heart failure, or other cardiovascular diseases. (3) Number of electrical cardioversions. (4) Proportion of patients on AADs at the end of follow-up. (5) PFA-related complications. (6) Assessment of the quality of life using standardized instruments (AFEQT, EQ5D). (7) Feasibility of achieving a complete block of the mitral isthmus and PWI using PFA (8) Proportion of patients with delayed conduction into LAA after mitral line (9) Number of patients that underwent repeated ablations during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent or long-standing persistent AF proved on at least two 12-lead ECG recordings more than one week apart or > 7-day EKG Holter recordings
- •Age ≥ 18 years at the time of study enrollment
- •Signed informed consent
排除标准
- •Paroxysmal AF
- •Sinus rhythm on the 12-lead ECG on admission unless recent external electrical cardioversion was carried out within the last six months and the patient is treated by amiodarone
- •LA diameter > 55 mm (measured in the parasternal long-axis view)
- •History of AF ablation in the past
- •History of cardiac surgery
- •Significant valvular defect
- •Age below 18 years
- •Pregnancy, breastfeeding
- •Any disease with a life expectancy <1 year
- •Terminal renal failure
- •History of pacemaker or defibrillator implantation
- •Significant thyroid disease
- •Uncorrected congenital heart disease or valvular obstruction
- •Obstructive hypertrophic cardiomyopathy
- •Active myocarditis
- •Constrictive pericarditis
- •Untreated hypothyroidism or hyperthyroidism
- •Adrenal insufficiency
- •Active vasculitis due to collagen vascular disease
- •Presence on a heart transplant waiting list (UNOS category 1A or 1B or equivalent). Patients on a non-acute heart transplant waiting list (UNOS category 2 or 7 or equal) are eligible for inclusion in the study
- •Recipient of any major organ transplant (e.g., lung, liver, heart)
- •Patient who is undergoing or has undergone cytotoxic or cytostatic chemotherapy and radiation therapy for the treatment of malignancy within six months before randomization or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if the localized disease is stable, with life expectancy > 2.5 years in the opinion of the investigator)
- •HIV positivity with a survival expectancy of less than five years due to HIV
- •Chronic kidney disease with glomerular filtration rate < 30 ml/min
- •Chronic dialysis treatment
- •Recent (within three months) self-reported history of alcoholism or illicit drug dependence
- •Any illness (e.g., psychiatric illness) or situation that, in the opinion of the investigator, could place the subject at significant risk, confound the results of the study, or significantly affect the subject's participation in the study
- •Unwillingness to participate.
研究组 & 干预措施
PVI
Pulmonary vein isolation
干预措施: pulsed-field ablation (Device)
PVI+
Pulmonary vein isolation supplemented by the additional lesions: left atrial posterior wall isolation, mitral and cavotricuspid isthmus lines
干预措施: pulsed-field ablation (Device)
结局指标
主要结局
Atrial fibrillation recurrence
时间窗: 1 year following ablation procedure
The primary endpoint will be a recurrence of AF (or atrial tachycardia, AT) lasting \>30 seconds as assessed using repeated 7-day ECG Holter monitoring in patients without anti-arrhythmic drugs (AADs) during the entire post-blanking follow-up, i.e., starting three months after the index procedure. All patients should complete a 12-month follow-up period.
次要结局
- Atrial fibrillation recurrence on AADs(1 year following ablation procedure)
- Complications(1 year following ablation procedure)
- Hospitalization rate(1 year following ablation procedure)
- Atrial Fibrillation Effect on Quality of Life (AFEQT)(1 year following ablation procedure)
- EuroQol Group questionnaire on quality of life(1 year following ablation procedure)
- Cardioversion(1 year following ablation procedure)