Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT03432494
Status:
TERMINATED
Last Update Posted:
2023-03-14
First Post:
2018-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
Early Feasibility Evaluation of Transmural Systems Transcaval Closure Device (TCD) for Transcaval Access Ports During Transcatheter Aortic Valve Replacement (TAVR)
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was kept open (via administrative hold) in anticipation of a device redesign and enrollment suspended, but funding never materialized to support the redesign.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) enables transcatheter aortic valve replacement (TAVR) in patients not eligible for femoral artery access. Currently the procedure is performed using devices, off-label, designed and marketed to close holes inside the heart and great vessels, manufactured by Abbott St Jude (Amplatzer Duct Occluder and Amplatzer Muscular VSD Occluder). Because these Amplatzer occluders are not designed to close transcaval access sites, they may not completely prevent bleeding.
This is an early feasibility study (EFS) evaluation of a purpose-built closure device for transcaval access. The device, the Transcaval closure device (TCD) will be evaluated for safety and performance to close transcaval access sites in patients ineligible for femoral artery access for TAVR.
This is an early feasibility study (EFS) evaluation of a purpose-built closure device for transcaval access. The device, the Transcaval closure device (TCD) will be evaluated for safety and performance to close transcaval access sites in patients ineligible for femoral artery access for TAVR.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18-H-N045 | None | None | View |