A Zero Fluoroscopy Maximum Voltage Guided Stepwise Approach Using IntellaMiFi Technology Compared to Linear Ablation of the Cavotricuspid Isthmus for Typical Atrial Flutter: the ZERO MAGIC Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Cumulative ablation duration
研究概览
简要总结
Catheter ablation of the cavo-tricuspid isthmus (CTI) is the curative first-line therapy for typical atrial flutter. Currently, two approaches are used in clinical practice. In contrast to the conventional linear ablation approach, the Maximum voltage-guided (MVG) strategy aims to limit ablation to high voltage areas (HVAs) representing the detectable correlate of relevant conducting bundles. Data from registries show that the MVG technique is sufficient to reach comparable clinical outcome with significantly shorter ablation duration when compared to the conventional linear strategy.
Despite growing evidence, however, data from properly powered prospective randomized trials are lacking and the linear approach still remains standard. In addition, data on radiation exposure are controversial.
As a substrate-based approach, the MVG strategy requires detailed mapping and signal analysis for identification of the individual architecture and exactly targeted energy application. However, the spatial mapping resolution of large tip catheters is limited. The use of the MicroFidelity catheter technology (IntellaMiFi) with high resolution mini-electrodes at the 8 mm catheter tip can be expected to further improve the feasibility of a voltage-guided approach. In addition, the MVG approach theoretically may encompass an increased risk for clinically inapparent reconduction. A prospective study with predefined invasive re-evaluation of persistent CTI block is needed to further evaluate this issue.
Objective of this prospective randomized study is evaluate the performance of the micro-sensor technology for zero-fluoroscopy voltage-guided ablation of typical atrial flutter (AFL) compared with a population undergoing conventional linear ablation including a predefined invasive re-evaluation of persistent CTI block in addition to clinical follow-up.
The study has been approved by the responsible ethics committee.
详细描述
Rationale:
Catheter ablation of the CTI represents the established curative first-line treatment for typical AFl. Although the acute and chronic efficacy is high, conventional ablation is still time consuming, requires a considerable amount of radiation as reported even in the most recent trials and treatment failure occurs.
The MVG catheter ablation of the CTI aims to limit energy delivery by selectively treating conductive bundles. Compared to the conventional linear strategy, a reduction of ablation and procedural time had been shown for the MVG technique. For several reasons, however, the current evidence is still not considered to be robust enough to suggest a general change in the ablation approach:
- Despite a reduction in ablation requirements, the additional time needed for voltage mapping often prolongs the total procedure duration.
- The spatial mapping resolution of large tip catheters, most often used for CTI-ablation is limited.
- Catheter positioning and CTI ablation is still guided by fluoroscopy with the well-known potential harm in the majority of electrophysiological centers. There are conflicting data for the MVG approach regarding radiation duration.
- The MVG approach theoretically encompasses an increased risk for clinically inapparent reconduction. A prospective study with predefined invasive re-evaluation of persistent CTI block is lacking.
Aims of the study:
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
Patients are blinded to the treatment group. During FU the physician is blinded to the treatment group.
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
- •Typical (CTI dependent) atrial flutter documented in a standard 12 lead surface ECG
- •Given class I indication for curative CTI ablation according to the current guidelines
- •Over 18 years old
- •Given informed consent
排除标准
- •Any contraindication for CTI ablation
- •Previous CTI ablation
- •BCB as procedural endpoint not assessable
- •CTI ablation conducted in association with further ablation procedures
- •Patients with CIED (e.g. pacemaker, ICD)
- •Tricuspid valve replacement
- •Right atrial thrombus
- •Pregnant or breastfeeding women
- •Abuse of drugs or alcohol
- •Age < 18 years
- •Incompliance to the treatment, e.g. necessary anticoagulation
- •Expected survival less than one year
- •Inability to understand the nature and rationale of the study
- •Inability to take part in the follow up
结局指标
主要结局
Cumulative ablation duration
时间窗: during procedure
Cumulative ablation duration (total radiofrequency (RF) energy delivery time) in seconds that is needed to achieve sustained complete CTI block (acute procedural efficacy)
次要结局
- Number of RF ablation points, which are necessary to achieve CTI block(during procedure)
- Fluoroscopy time(during procedure)
- Total amount of RF energy delivery for CTI block(during procedure)
- Number of participants with persistence of CTI block(3 months follow-up)
- Rate of procedure related adverse events(during procedure)
- Fluoroscopy exposure(during procedure)