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

NCT02280824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2019-02-15

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Valve Stenosis

Interventions

PROCEDURE

CA-TAVR

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

DEVICE

Amplatzer Duct Occluder

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
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-30
Primary Completion
2017-07-27
Completion
2018-12-28
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 NCT02280824 on ClinicalTrials.gov