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

Phase 1
Completed
Conditions
Aortic Valve Stenosis
Registration Number
NCT02280824
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
172
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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 access1 year

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (15)

Medstar Washington Hospital Center

🇺🇸

Washington, District of Columbia, United States

Emory University

🇺🇸

Atlanta, Georgia, United States

NorthShore University HealthSystem, Evanston Hospital

🇺🇸

Evanston, Illinois, United States

Advocate Heart Institute

🇺🇸

Oakbrook Terrace, Illinois, United States

Cardiovascular Institute of the South

🇺🇸

Houma, Louisiana, United States

Ochsner Health System

🇺🇸

New Orleans, Louisiana, United States

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

Wake Forest University

🇺🇸

Winston-Salem, North Carolina, United States

Oklahoma Heart Institute

🇺🇸

Tulsa, Oklahoma, United States

York Hospital

🇺🇸

York, Pennsylvania, United States

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Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States

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