Surgical PA-LAA Shunting: a Feasibility Study (PA-LAA)
Surgical PA-LAA Shunting for Management of Systemic Embolization in Patients With Atrial Fibrillation: a Feasibility Study
Atrial fibrillation is common and increases the risk of stroke. Traditionally patients are treated with blood thinning medications or at the time of surgery the part of the heart where blood clots form is cut out. Surgically cutting out the left atrial appendage can be difficult and complications can occur. An alternative strategy is to create a tunnel to increase blood flow and wash out the part of the heart where clots form.
This strategy has not been previously studied. The purpose of this study is to determine if creating a tunnel to increase blood flow is feasible and safe.
研究概览
详细说明
The goal is to understand the potential avenues to increase Left Atrial Appendage (LAA) flow in patients with Atrial Fibrillation (AF) to minimize systemic embolization risk. Flow modeling demonstrates that the anatomy of the LAA results in decreased velocities in the LAA apex. Introduction of a 3-4mm shunt in the apex can result in increased velocity, less stasis and a lower propensity for thrombus formation. Small (<8mm) inter-chamber shunts can exist in humans with no long term hemodynamic consequences in otherwise structurally normal hearts - making a strategy of pulmonary artery (PA) to LAA shunt an attractive potential therapy given anatomic proximity and gradient differential between the cardiac chambers.
This will be a 5 patient first-in-human feasibility study. The population will include patients undergoing CABG or other cardiovascular surgery with AF and a CHADS2 score >1 in whom the treating team deems traditional therapy with anticoagulants is prohibitive or ineffective (dialysis or EGFR preoperatively <15, previous bleeding with non-reversible pathology, clinically deemed contraindicated to oral anticoagulant). The intervention will be PA-LAA shunt creation at the time of surgery. As this is a single arm study there will be no comparison group.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Ottawa、Ontario、加拿大、K1Y4W7
- University of Ottawa Heart Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years undergoing CV surgery
- History of AF with a CHADS2 score >1
Relative contraindication to OAC as determined by the heart team
- Dialysis or preoperative eGFR of <15
- Bleeding on DOAC/Coumadin with non-reversible pathology
- Other medical condition that makes the patient ineligible for OAC
- Anatomic proximity of LAA and PA on preoperative CT scan suitable for shunt creation
Exclusion Criteria:
- LVEF <40%
- History of VTE - either DVT or PE
- Resting baseline preoperative O2 sats <98%
- Inability of the patient to provide written informed consent
- Greater than moderate valvular heart disease which is not to be addressed during surgical intervention
- Documented mPA to PCWP <5mmHg
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Procedure arm
At the time of surgery a covered stent will be inserted through the atriotomy into the left pulmonary artery and balloon dilated to stabilize the device.
The target shunt diameter will be 3.5-4 mm to minimize LAA stasis.
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At the time of surgery a covered stent will be inserted through the atriotomy into the left pulmonary artery and balloon dilated to stabilize the device.
The target shunt diameter will be 3.5-4 mm to minimize LAA stasis.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Composite of device safety and performance
大体时间:3 months
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At three months feasibility will be met if there is no:
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Device related performance - maintaining patency
大体时间:1 year
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Shunt patency as assessed by TEE
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1 year
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Systemic embolization
大体时间:1 year
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Systemic embolization - includes stroke, TIA, MI or peripheral embolization attributable to either LAA thrombus or paradoxical embolization as clinically diagnosed by treating physician
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1 year
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Systemic saturations
大体时间:1 year
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Resting saturations <92% - threshold
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1 year
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Need for intervention to close the shunt
大体时间:1 year
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Need for intervention to close the shunt either surgically or percutaneously to
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1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
LAA Thrombus Prevention的临床试验
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Vanderbilt University Medical CenterBoehringer Ingelheim完全的心房颤动 | 左心耳血栓形成 | 设备相关血栓 | Watchman LAA 闭合装置美国
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Coherex Medical完全的非瓣膜性阵发性、持续性或永久性心房颤动 | LAA 解剖适合经皮技术治疗 | 左心房潜在血栓形成的抗凝指征
PA-LAA shunt的临床试验
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Central Clinical Hospital of the Ministry of Internal...招聘中
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Xijing HospitalThe First Affiliated Hospital with Nanjing Medical University; Peking University First Hospital 和其他合作者尚未招聘
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AtriCure, Inc.Population Health Research Institute招聘中