Treatment Based on High Precision Cardiac Mapping: Advancing Personalized Outcomes Through Optimized Localization
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- VT recurrence
研究概览
简要总结
APOLO-VT aims to evaluate the feasibility, safety, and clinical impact of an integrated multimodal mapping workflow combining non-invasive structural and functional substrate characterization using Volumetric Electrocardiographic Imaging (ECGi) with invasive Electroanatomical Mapping (EAM) to support Ventricular tachycardia (VT) ablation targeting and verification.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Diagnosis of structural heart disease (ischemic or non-ischemic cardiomyopathy).
- •Documented sustained monomorphic VT (clinical or inducible), or recurrent ICD therapies for VT.
- •Scheduled for catheter ablation of VT according to current international guidelines.
- •Ability to provide written informed consent.
- •Ability to remain upright or seated to allow a video for 3D torso reconstruction for ECGi acquisition.
排除标准
- •Age <18 years.
- •Pregnant or breastfeeding women.
- •Inability to provide informed consent due to physical or mental condition.
- •Contraindication to computed tomography or cardiac magnetic resonance (magnetic resonance imaging-incompatible devices, claustrophobia).
- •Contraindication to contrast agents (gadolinium allergy or severe renal dysfunction with estimated glomerular filtration rate <30 mL/min/1.73 m²).
- •Inability to remain upright for torso 3D reconstruction required for ECGi.
- •Life expectancy <1 year due to non-cardiac comorbidity.
研究组 & 干预措施
Ablation strategy
Ablation is guided by an integrated non-invasive mapping strategy, combining structural targets from late gadolinium enhancement cardiac magnetic resonance and/or functional targets (deceleration zones) from non-invasive Volumetric ECGi in sinus rhythm (SR) and pacing protocol; both are merged with invasive electroanatomic mapping. Before ablation, programmed stimulation assesses VT inducibility; if VT is induced, its Volumetric ECGi-derived critical isthmus is added as a further target. Lesions are delivered to these non-invasively defined target regions, with adequacy defined as loss of local capture on pacing at the ablation site. Afterwards, SR and paced Volumetric ECGi remapping reassesses residual deceleration zones, with further ablation and remapping if substrate persists. Programmed stimulation is repeated, with invasive remapping and ablation for validation. Acute procedural success requires VT non-inducibility and elimination of relevant functional substrate.
干预措施: ACORYS Mapping System (Device)
结局指标
主要结局
VT recurrence
时间窗: 12 months
Recurrence of sustained ventricular tachycardia after the index ablation.
次要结局
- Acute procedural outcomes(Baseline)
- Procedure complications(Baseline)
- Electrophysiological endpoints(Baseline)
- Clinical outcomes during follow-up(12 months)
研究者
Ivo Roca
Head of Arrhythmia Section. Cardiovascular Institute.
Hospital Clinic of Barcelona