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Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement

NCT03432494 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-03-14

Study results available
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Summary

Background:

Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement. Not all patients are eligible for TAVR using standard access through the artery in the groin, because the artery is too small or too diseased. In this study, TAVR is performed using a new technique called transcaval access. The catheter is placed in the artery deep in the body by crossing through the wall of a deep vein. The connection between that vein and the aorta is closed with a new metallic device they are testing. This is called a transcaval closure device (TCD).

Objective:

To test the safety and early feasibility of closure of transcaval aortic access sites using the TCD after TAVR.

Eligibility:

Adults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by the standard artery approach

Design:

Participants will be assessed by heart experts including cardiologists and surgeons.

Participants will have TAVR by the transcaval approach. A small catheter will be passed between the largest vein in the body and the nearby largest artery (aorta), inside the abdomen. Through this catheter, the TAVR will be implanted in the usual way.

After, doctors will implant the TCD by catheter to close the hole made in the aorta.

Participants will be X-rayed. A dye will be injected to view the TCD device.

Participants will get standard TAVR care afterwards. They will have physical exams, blood tests, and scans.

Participants will have a follow-up scan within 1 month and after 12 months.

Participants will have follow-up visits and phone calls 6 and 12 months after the procedure.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Transcaval closure device (TCD)

Transcaval access and closure using the Transmural Transcaval Closure Device (TCD) at the time of medically-necessary transcatheter aortic valve replacement (TAVR).

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Robert J Lederman, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-07
Primary Completion
2018-04-30
Completion
2019-04-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03432494 on ClinicalTrials.gov