Transcaval Access for Transcatheter Aortic Valve Replacement in People 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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medstar Washington Hospital Center, Washington D.C., District of Columbia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CA-TAVR

Procedure

Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access

Amplatzer Duct Occluder

Device

Primary outcomes

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

Time frame: 1 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

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2018
First posted: Nov 3, 2014
Registry last updated: Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed