Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
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|ClinicalTrials.gov Identifier: NCT03432494|
Recruitment Status : Suspended (on hold due to planned modifications to the test device)
First Posted : February 14, 2018
Last Update Posted : July 28, 2021
TAVR is a common therapy for people with heart problems as a better option than surgery. It stands for transcatheter aortic valve replacement. It is usually done by inserting a catheter (thin tube) through a groin artery. But this isn t safe for everyone. Researchers developed 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).
To test the safety and early feasibility of closure of transcaval aortic access sites using the TCD after TAVR.
Adults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by the standard artery approach
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.
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis||Device: Transcaval closure device (TCD)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Feasibility Evaluation of Transmural Systems Transcaval Closure Device (TCD) for Transcaval Access Ports During Transcatheter Aortic Valve Replacement (TAVR)|
|Actual Study Start Date :||February 7, 2018|
|Estimated Primary Completion Date :||December 20, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: Study Arm 1
Subjects undergoing transcaval access for TAVR
Device: Transcaval closure device (TCD)
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
- The primary endpoint is Technical success. [ Time Frame: Exit from the catheterization laboratory ]The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present:-Alive;-Successful delivery of the TCD, and retrieval of the TCD delivery system;-Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure;-No additional unplanned or emergency surgery or reinterventionrelated to the TCD or delivery system;-Adjunctive balloon aortic tamponade is permissible and consistent with technical success.
- Device success [ Time Frame: 30 days; 12 months ]A key performance endpoint is Device success. This endpoint ismeasured at 30 days and 12- months. All of the following must bepresent-Alive;-Original intended TCD in place;-No additional surgical or interventional procedures related to access or the device after exit from the cath lab;-Intended performance of the TCD, including all of --Structural Performance: No migration, embolization, detachment, fracture, hemolysis, or endarteritis related to the TCD; --Hemodynamic performance: No abdominal aortic obstruction caused by the TCD implant; --Absence of para-device complications (large retroperitoneal hematoma, pseudoaneu-rysm, distal thromboembolism, or pulmonary thromboembolism)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432494
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Robert J Lederman, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|