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

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	21 - 99
Updated:	2/17/2019
Start Date:	October 30, 2014
End Date:	December 28, 2018

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

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.

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.

- 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.

We found this trial at

sites

Oklahoma Heart Institute

Tulsa, Oklahoma 74137

from

Tulsa, OK