High Density Scar Guided Atrial Fibrillation Mapping (HD SAGA) / High Density Scar Guided Atrial Fibrillation Mapping StablePoint (HD SAGA S)/ High Density Scar Guided Atrial Fibrillation Mapping HD Grid (HD SAGA H)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Scar Volume
研究概览
简要总结
HD SAGA:
There is increasing evidence that having AF is associated with some scarring of the upper chamber of the heart, the left atrium. There is also evidence that the amount of scarring can predict ablation success rates. Recently, rapid ultra high density mapping equipment has become available and this has the capability of defining the electrical scar in the atrium in detail. The equipment used to do this is standard approved equipment for the procedure but its use for making scar maps has not been fully assessed.
In the mapping phase of the study therefore, the aim will be to collect high density scar maps in AF and normal rhythm to see how they compare. Maps will be collected in different ways to see if that changes their accuracy. The study will also assess if the values previously suggested as representing scar with lower density mapping systems are still appropriate where high density mapping equipment is used. The results from this study will help to improve the understanding of scar in the atrium and help demonstrate the most efficient way to collect scar information using this high density mapping equipment. In the future, clinicians may be able to use these very detailed scar maps to tailor and refine the way they ablate patients with AF, though the focus of the current study is just on collecting the scar information.
While identifying areas requiring ablation is important to an ablation procedure, the other important aspect is the efficacy of ablation. Until now, we have been reliant on assessing our inputs into an ablation (such as the level of contact and the power delivered) but have been limited in the assessment of the output of an ablation in terms of lesion characteristics. New ablation catheter technology is now available which can assess the localised impedance drop with ablation. This is likely a better surrogate for lesion parameters than what we have previously had available and merits further study. Based on such study, we may be able to define targets for ablation which would help to guide future ablations.
HD SAGA S:
Approval amendment March 2021 In addition to the above, using new catheter technology incorporating contact force into the assessment of ablation lesion efficacy.
HD SAGA H:
Approval amendment March 2021 Using new mapping catheter (HD Grid) and algorithms (HD Wave) to compare scar maps between AF and SR and pre-establish pulmonary vein isolation lines.
详细描述
HD SAGA:
The study would propose to use the Rhythmia Ultra High Density (UHD) mapping system (Boston Scientific) firstly to generate scar maps to determine if the results are comparable with previous work using lower density systems. Scar maps would be acquired in 3 groups of patients. The first group would be Redo-persistent AF ablation cases as these patients would have expected LA scar (iatrogenic and non-iatrogenic) from their previous ablation procedure. De novo persistent AF patients who would be expected to have non-iatrogenic scar. De novo paroxysmal AF patients who would be expected to have no or minimal scar. In redo AF patients, the validity of the scar maps would be further explored by undertaking re-isolation of veins based on discontinuities in the pulmonary vein isolation lines. If this is proven to be effective, it would demonstrate that the scar picked up by the system is genuine and may also suggest a more effective use of UHD systems for redo-pulmonary vein isolation (PVI).
In the ablation phase, we would be assessing the effect of ablation on the localised ablation characteristics of the tissue to assess how this is affected by ablation. From previous work, using conventional, wide area impedance measurements, there is a notable plateau in the impedance drop with ablation suggesting a point beyond which there is minimal efficacy gain from further ablation. One would expect this would be even more apparent with localised impedance.
Original Hypothesis - mapping phase An UHD mapping system can be utilised to generate automated, rapid, high density atrial scar maps in AF to guide a scar-based ablation strategy.
Original Hypothesis - ablation phase Localised Impedance will fall during ablation and this fall will plateau, suggesting a biophysical target for ablation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •trial Fibrillation, Scheduled for ablation on clinical grounds Able/willing to consent to procedure/research protocol No contraindication to clinical ablation
排除标准
- •Unable/unwilling to consent Contraindication to clinical ablation
结局指标
主要结局
Scar Volume
时间窗: Through study completion, an average of 1 year
Quantification of scar volumes - presented as a proportion of the total atrial geometry volume
Impedance values with ablation
时间窗: Through study completion, an average of 1 year
Collection of localised and conventional impedance during ablation
Scar volume and pulmonary vein isolation line gaps
时间窗: Through study completion, an average of 1 year
Scar volume and pulmonary vein isolation line gaps between AF and SR
次要结局
- Compare scar volumes in AF and sinus rhythm in the same patient(Through study completion, an average of 1 year)
- Localised impedance fall versus electrogram attenuation(Through study completion, an average of 1 year)
- Localised impedance fall during ablation(Through study completion, an average of 1 year)
- Compare localised with conventional impedance values during ablation(Through study completion, an average of 1 year)
- Compare contact force measurements to local impedance(Through study completion, an average of 1 year)
- Compare left atrial scar area between omnipolar and bipolar mapping in atrial fibrillation(Through study completion, an average of 1 year)
- Compare left atrial scar areas in bipolar maps between sinus rhythm and atrial fibrillation(Through study completion, an average of 1 year)
- Confirm Scar Thresholds(Through study completion, an average of 1 year)
- Compare maps generated using internal unipolar reference and Wilson's Central Terminus(Through study completion, an average of 1 year)
- Localised impedance fall versus pacing capture(Through study completion, an average of 1 year)
- Compare left atrial scar area between omnipolar and bipolar mapping in sinus rhythm(Through study completion, an average of 1 year)
- Compare left atrial scar area in omnipolar maps between sinus rhythm and atrial fibrillation(Through study completion, an average of 1 year)
- Compare identification of pulmonary vein isolation gaps between omnipolar and bipolar maps(Through study completion, an average of 1 year)
- Compare identification of pulmonary vein isolation gaps between sinus rhythm and atrial fibrillation(Through study completion, an average of 1 year)