Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access

Study Overview
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Brief Summary
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Background: - Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. For this technique, doctors make a hole between the largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they replace the valve through a tube they put in the groin vein. Then they close the hole between the vein and the artery using a device designed to close holes in the heart. This study tests the device for this new, off-label use. Objective: - To further study the safety and effectiveness of transcaval TAVR. Eligibility: - Adults age 21 and older who would benefit from TAVR but for whom standard techniques are not suitable. Design: Participants will be selected by a team of heart specialists and others. Participants will have a computed tomography (CT) scan with or without contrast dye. Participants will have blood tests. Participants will have transcaval TAVR. Participants will receive the same standard care as for all patients with TAVR. Participants will also have another CT scan, or an MRI or ultrasound, before they leave the hospital, and again after about 30 days and after about 12 months. Participants will be contacted 1 and 6 months afterwards and will have another visit 1 year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a physical exam.

Detailed Description
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Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) has enabled transcatheter aortic valve replacement (TAVR) in a small number of patients who have no good options for standard percutaneous femoral access or for standard surgical access to the cardiac apex or to the ascending aorta. In this prospective registry we will collect data from multiple medical centers as they offer transcaval TAVR to patients with extreme or prohibitive risk of conventional TAVR.

Official Title
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Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: CA-TAVR
* Device: Amplatzer Duct Occluder


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Adults age greater than or equal to 21 years Severe symptomatic de novo aortic valve stenosis or bioprosthetic aortic valve failure for which transcatheter aortic valve replacement (TAVR) is felt beneficial according to the consensus of the institutional multidisciplinary heart team Extreme risk or inoperability for TAVR via conventional femoral artery, trans-apical, or trans-aortic access in the determination of the multidisciplinary heart team. This determination includes an in-person consultation by at least one cardiac surgeon member of the heart team. Anatomic eligibility for caval-aortic TAVR, graded as favorable or feasible based on NHLBI core lab assessment of the baseline CT examination. EXCLUSION CRITERIA: Unable or unwilling to consent to participate Anatomic eligibility for caval-aortic TAVR graded as unfavorable based on NHLBI core lab assessment of the baseline CT examination Unlikely to benefit from caval-aortic TAVR Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access | Procedure: CA-TAVR<br>* Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access<br>Device: Amplatzer Duct Occluder<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access | The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcaval, TAVR, AMPLATZER(R) Occluder