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

Completed · Phase 1

Conditions studied: Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT02280824

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

172

Starts

2014-10-30

Expected to finish

2018-12-28

Last updated by the study team

2019-02-15

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Medstar Washington Hospital Center — Washington D.C., 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
• Vanderbilt Heart and Vascular Institute — Nashville, Tennessee, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• INOVA Fairfax Hospital — Falls Church, Virginia, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• Carilion Medical Center — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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