Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty
In this study, the investigators evaluate whether routine double inflation of the valve could have a lasting impact. The investigators hypothesize that a routine second reinflation of the balloon, or "double tap", will improve flow across the valve when compared to a single inflation. The investigators hypothesize that "double tap" (1) will decrease mean gradient between first and second inflation during the procedure, (2) will decrease mean gradient on immediate post procedure and 30 day postprocedure echocardiograms when compared to mean gradient gradient after single inflation. Less obstruction indicated by lower mean gradient early after deployment may translate to improved 5 and 10 year outcomes. Furthermore, the investigators hypothesize that this small change in technique will have no effect on procedure time or complications and the change will not result in any increase in perioperative vascular complications, or new permanent pacemaker insertion.
The primary objective of this study is to determine if double valve inflation during a TAVR procedure improves valve area and mean gradients as measured by echocardiogram immediately following the procedure and at 30 days follow up.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Erin Ross
- 电话号码：8059488278
- 邮箱：eross1@cmhshealth.org
学习地点
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California
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Ventura、California、美国、93003
- 招聘中
- Community Memorial Hospital
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接触：
- Erin Ross
- 电话号码：805-948-8278
- 邮箱：eross1@cmhshealth.org
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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
取样方法
研究人群
描述
Inclusion Criteria:
- Male or female ≥18 years of age
- Diagnosis of severe native valve aortic stenosis
- Meets the standard of care indications to undergo TAVR procedure (aortic valve area <1.0 cm2 or mean pressure gradient >40 mmHg or peak velocity >4.0 m/s or aortic valve area index <0.6).
- Provided informed consent.
Exclusion Criteria:
- History of prior aortic valve replacement
- Pre-existing moderate to severe aortic regurgitation
- Lacking pre-procedure echocardiogram
- Patients planning to undergo multiple valve replacements simultaneously
- Intraoperative arrhythmia
- Intraoperative hemodynamic instability
- Intraoperative complication during initial inflation (such as: aortic dissection, coronary artery occlusion, coronary artery dissection)
- At the discretion of the principal investigator, any reason that the potential subject may be unfit for participation, such as frailty.
学习计划
研究是如何设计的？
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Prospective
The prospective phase will enroll patients planning to undergo TAVR, at the discretion of Drs.
Wan and Fatemi, and if they meet all of the inclusion criteria and none of the exclusion criteria.
All patients who provide consent will undergo the TAVR procedure where the valve will be double inflated.
Echocardiogram results and procedure details will be collected as data.
At the patient's 30-day follow-up clinic visit, as per standard of care, they will be re-evaluated with an echocardiogram.
Details from that follow-up visit and the echocardiogram results will be collected as data.
Prospective enrollment will begin upon IRB approval and we plan to continue enrollment until December 31, 2023, or once 200 participants are reached, whichever comes first.
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The prospective phase will enroll patients planning to undergo TAVR, at the discretion of Drs.
Wan and Fatemi, and if they meet all of the inclusion criteria and none of the exclusion criteria.
All patients who provide consent will undergo the TAVR procedure where the valve will be double inflated.
Echocardiogram results and procedure details will be collected as data.
At the patient's 30-day follow-up clinic visit, as per standard of care, they will be re-evaluated with an echocardiogram.
Details from that follow-up visit and the echocardiogram results will be collected as data.
Prospective enrollment will begin upon IRB approval and we plan to continue enrollment until December 31, 2023, or once 200 participants are reached, whichever comes first.
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Retrospective
The retrospective phase will collect data from previous TAVR procedures completed between February 2019 and October 1, 2021.
Data from up to 200 patient charts will be collected using the Society of Thoracic Surgeons/American College of Cardiology that is maintained by the CMH Cardiology Department.
The population will be de-identified as the purpose is to obtain descriptive information from the medical records to utilize for propensity match scoring.
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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 |
|---|---|---|
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Valve area
大体时间：Immediately following the procedure
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Valve area as measured by echocardiogram
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Immediately following the procedure
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Valve area
大体时间：At 30 days follow up
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Valve area as measured by echocardiogram
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At 30 days follow up
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Mean gradient
大体时间：Immediately following the procedure
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Mean gradient as measured by echocardiogram
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Immediately following the procedure
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Mean gradient
大体时间：At 30 days follow up
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Mean gradient as measured by echocardiogram
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At 30 days follow up
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合作者和调查者
调查人员
- 首席研究员：Jennifer Wan, MD、Community Memorial HealthCenter
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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.