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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 1

Conditions

Aortic Valve Stenosis

Treatments

Procedure: CA-TAVR

Device: Amplatzer Duct Occluder

Study type

Interventional

Funder types

NIH

Identifiers

NCT02280824

999915009

15-H-N009

Details and patient eligibility

About

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.

Full 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.

Enrollment

172 patients

Sex

All

Ages

21 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.