跳至主要内容
临床试验/NCT02917044
NCT02917044终止不适用

Use of a High Density Mapping System to Complete Wide Area Circumferential Ablation of the Pulmonary Veins and Avoid Ostial Segmental Ablation

Imperial College Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
2
主要终点
Total time in minutes required to produce isolation of veins per WACA

研究概览

简要总结

This is a prospective, multicentre, randomized single blind, parallel group study to be conducted in the UK (2 sites).Approximately 48 patients will be recruited aiming for 40 eligible for randomization. The study is designed to compare the operator's best attempt at WACA completion with and without Rhythmia guidance

详细描述

BACKGROUND Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia occurring in 1-2% of the general population. AF can be associated with debilitating symptoms and confers an increased risk of death, stroke, heart failure and hospitalization. As such there is a need for effective therapies for AF. In particularly catheter based therapies, which can limit the need for chronic drug therapy, are becoming more widely accepted.

The development of AF requires both a trigger and susceptible substrate. Ectopic activity originating within the pulmonary veins (PVs) is a widely recognised factor in the genesis of paroxysmal AF, whilst electrical, contractile and structural remodelling of atrial myocardium are each important contributing factors to the arrhythmogenic substrate in AF.

An early strategy in paroxysmal AF (PAF) was to target ectopic triggers coming from the PV via ostial segmental ablation (OSA). Here radiofrequency (RF) ablation was applied close to the PV ostia at sites of early signals, usually until PVs were electrically isolated from the left atrium (LA). This approach resulted in a success rate, with regard to freedom from AF after a single procedure, of 65-90% after 1 year but closer to 50% after 5 years. The recognition of PV stenosis as a complication of RF delivery within a PV, as well as the recognition that initiation sites could be located in the antrum led to a shift in ablation strategy towards wider encirclement of the PVs using wide area circumferential ablation (WACA) using electroanatomical mapping to guide RF delivery. This resulted in improved success rates in a head-to-head comparison with OSA and it is possible that this relates to substrate modification inherent in this approach.

Recurrence of AF remains problematic following ablation. Pulmonary vein reconnection after ablation is thought to contribute to the majority of recurrent episodes of AF in paroxysmal AF. Electrical isolation of the PVs is often not achievable with WACA alone - 95% of patients had residual connections following WACA alone in one study. Most clinicians at this juncture will look for any obvious gaps in the line and ablate if there are early PV signals. If this is unsuccessful then it is often necessary to resort to OSA to achieve PV isolation. In essence a large proportion of PV isolation procedures, which started with a WACA strategy, are in fact a hybrid of WACA and OSA. This both has the potential to increase the complication rate by risking PV stenosis and reducing efficacy through omitting important substrate modification and allowing residual connection of part of the antrum and the LA.

The introduction of Rhythmia, a novel electroanatomical mapping system with the potential to rapidly acquire high density electroanatomical data, may allow an alternative strategy and more efficient targeting of gaps in WACA lines. The pilot data shows that the system is particularly adept in assessing gaps in ablation lines including WACA lines. Mapping and targeting such gaps may hold the key to efficiently completing PV isolation after an initial WACA line is performed.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ECG documented AF
  • Listed for AF ablation by referring physician
  • Planned ablation includes a first-time PVI.
  • Patient signed informed consent form

排除标准

  • Age <18 or >80
  • LA diameter >60mm
  • AF secondary to transient correctible abnormalits (e.g. electrolyte imbalance, thyrotoxicosis, recent infective or inflammatory process)
  • Intra-atrial thrombus or tumour
  • Renal failure requiring haemodialysis
  • Heart failure with NYHA III-IV or EF<35%

研究组 & 干预措施

Group A - Standard Care

Active Comparator

The operator will attempt to complete the WACA lesion set using standard techniques. These include ablating any obvious gaps in the lesion set, ablating at the WACA line in a location radial to the earliest PV signal measured by the Orion catheter situated within the PV, and guided by amplitude and dV/dt of signals along the WACA lesion set measured using the mapping catheter. If this fails the operator will resort to OSA as per their usual practice.

干预措施: Atrial Fibrillation Ablation (Procedure)

Group A - Standard Care

Active Comparator

The operator will attempt to complete the WACA lesion set using standard techniques. These include ablating any obvious gaps in the lesion set, ablating at the WACA line in a location radial to the earliest PV signal measured by the Orion catheter situated within the PV, and guided by amplitude and dV/dt of signals along the WACA lesion set measured using the mapping catheter. If this fails the operator will resort to OSA as per their usual practice.

干预措施: Catheters used to isolate pulmonary veins (Device)

Group B - Rhythmia mapping

Experimental

The operator will form Rhythmia maps focussing on the region of the WACA line surrounding the non-isolated vein(s) whilst pacing from CS. This will be used as a means of targeting RF ablation to gaps in the WACA line (in addition to use of standard observation of signals as per group A). If this fails then the operator will resort to OSA as per their usual practice.

干预措施: Catheters used to isolate pulmonary veins (Device)

Group B - Rhythmia mapping

Experimental

The operator will form Rhythmia maps focussing on the region of the WACA line surrounding the non-isolated vein(s) whilst pacing from CS. This will be used as a means of targeting RF ablation to gaps in the WACA line (in addition to use of standard observation of signals as per group A). If this fails then the operator will resort to OSA as per their usual practice.

干预措施: Atrial Fibrillation Ablation with HD mapping to isolate PVs (Procedure)

Group B - Rhythmia mapping

Experimental

The operator will form Rhythmia maps focussing on the region of the WACA line surrounding the non-isolated vein(s) whilst pacing from CS. This will be used as a means of targeting RF ablation to gaps in the WACA line (in addition to use of standard observation of signals as per group A). If this fails then the operator will resort to OSA as per their usual practice.

干预措施: Rhythmia HD mapping (Device)

结局指标

主要结局

Total time in minutes required to produce isolation of veins per WACA

时间窗: Procedural - i.e. assessed over procedure duration only (about 3 hours)

Following first pass ablation with WACA, if either vein is not isolated the patient will be randomized into group A or B. The total RF time taken to isolate the veins for that WACA will be measured as one of 2 joint primary outcome measures.

Total number of radiofrequency ablation lesions to produce isolation of veins per WACA

时间窗: Procedural - i.e. assessed over procedure duration only (about 3 hours)

Following first pass ablation with WACA, if either vein is not isolated the patient will be randomized into group A or B. The total number of lesions (each lesion being 30s in duration) to isolate the veins for that WACA will be measured as one of two joint primary outcome measures.

次要结局

  • Percentage of patients with successful PV isolation(Procedural - i.e. assessed over procedure duration only (about 3 hours))
  • Percentage of patients suffering symptomatic PV stenosis(3 months)
  • Whether ostial ablation is required in each case (Yes/No)(Procedural - i.e. assessed over procedure duration only (about 3 hours))
  • Number of radiofrequency ablation lesions required within the WACA lesion set(Procedural - i.e. assessed over procedure duration only (about 3 hours))
  • Total procedural time (in mins) required to produce PV isolation(Procedural - i.e. assessed over procedure duration only (about 3 hours))
  • Percentage of patients with AF recurrence(3 months)
  • Total radiofrequency ablation time (in mins) within the WACA lesion set(Procedural - i.e. assessed over procedure duration only (about 3 hours))
  • Total number of radiofrequency ablation lesions required to produce PV isolation per patient(Procedural - i.e. assessed over procedure duration only (about 3 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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