Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Durable PVI (per vein)
研究概览
简要总结
We designed a study to evaluate the impact of a two systematic strategies for PVI with the octaspline, balloon-based PFA (B-PFA) catheter. We hypothesized that the addition of electroanatomic guidance is non-superior to fluoroscopy-only guidance in achieving durable PVI.
详细描述
Study design This is a single-center, randomized clinical study enrolling consecutive paroxysmal or persistent AF patients undergoing PVI with a B-PFA catheter (ClinicalTrials.gov identifier: pending). Patients will be randomized in a 1:1 basis to a fluoroscopy-only strategy vs. a strategy based on the same fluoroscopy workflow but with the addition of electroanatomic mapping (EAM).
Procedures will be carried out under deep sedo-analgesia with propofol and fentanyl. Patients will be scheduled for systematic, invasive remapping of the left atrium (LA) and pulmonary veins (PVs) a minimum of 30 days after index ablation, regardless of recurrence status.
The study will be carried out in University Hospital 12 de Octubre, a tertiary academic hospital, and has already received approval from the corresponding Institutional Review Board (code 23/208, mod. 2).
Patient data will be handled according to the current General Data Protection Regulation 2016/679 of the European Parliament (EU-GDPR) and the Council of 27 April 2016 on Personal Data Protection as well as national and local regulations regarding patient autonomy, and rights and obligations in terms of information and clinical documentation.
After a run-in phase of 10 cases per operator, 96 patients will be consecutively enrolled during a 4-month period (Figure 1).
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)
盲法说明
All events related to the dual primary efficacy outcomes and primary safety outcome will be reviewed by an independent committee. These physicians will be responsible for reviewing the acute and chronic (>30 days) left atrial maps. Their role will be to determine PVI status and to define the type of adverse event according to its severity and relevance to the study. This committee will consist of three electrophysiologists who will not participate in the ablation or remapping procedures and who will be blinded to the characteristics of the index procedure.
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
- •≥18 years old
- •Diagnosed with paroxysmal or persistent AF
- •Clinical indication to undergo PVI
排除标准
- •Prior PVI or left atrial linear ablation
- •Severe frailty or life expectancy <1 year
- •Unwillingness or inability to provide informed consent
- •Ablation at sites beyond PVI or indication for additional electrophysiological study
- •Contraindication or intolerance to heparin
- •Presence of left atrial thrombus
- •Congenital heart disease
- •Pregnancy, ongoing or planned in the following 6 months
结局指标
主要结局
Durable PVI (per vein)
时间窗: 30 days after index procedure
proportion of pulmonary veins durably isolated (i.e.: more than 30 days after index procedure);
Durable PVI (per patient)
时间窗: 30 days after index procedure
proportion of patients with all pulmonary veins durably isolated (i.e.: more than 30 days after index procedure);
次要结局
- Fluoroscopy exposure(At index procedure)
- PFA reversibility(30 days after index procedure)
研究者
Daniel Rodríguez Muñoz
PhD and Medical Doctor Consultant in Cardiac Electrophysiology, Principal Investigator
Hospital Universitario 12 de Octubre