Brief Title
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Official Title
Early Feasibility Evaluation of Transmural Systems Transcaval Closure Device (TCD) for Transcaval Access Ports During Transcatheter Aortic Valve Replacement (TAVR)
Brief Summary
Background: 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). 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.
Study Type
Interventional
Primary Outcome
The primary endpoint is Technical success.
Secondary Outcome
Device success
Condition
Aortic Stenosis
Intervention
Transcaval closure device (TCD)
Study Arms / Comparison Groups
Study Arm 1
Description: Subjects undergoing transcaval access for TAVR
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
12
Start Date
February 7, 2018
Completion Date
December 31, 2020
Primary Completion Date
December 30, 2020
Eligibility Criteria
- INCLUSION CRITERIA: - Consents to participate in this study and all related clinical follow-up procedures - Adults age greater than or equal to 21 years - Undergoing transcatheter aortic valve replacement (TAVR) based on the clinical assessment of the multidisciplinary heart team - Ineligible for femoral artery access for the selected transcatheter heart valve (THV) according to the THV manufacturer instructions for use. (Note Corevalve Evolut R: greater than or equal to 5mm; Evolut PRO 23, 26, 29 mm valves and Ev lut R 34 mm: greater than or equal to 5.5 mm; Edwards Sapien 3, 23-26mm: 5.5 mm; Edwards Sapien 3, 29mm: 6.0mm; Anatomic ineligibility also considers patient-specific pattern of iliofemoral calcium and tortuosity.) - Eligible for transcaval access based on Core lab analysis of the baseline abdomen/pelvis CT indicating a calcium-free target window on the abdominal aorta; a target greater than or equal to 15mm from the lowest main renal artery or aorto-iliac bifurcation; no important interposed structures; a projected intravascular centerline distance from the lower femoral head to the target at least 5cm less than the intended THV introducer sheath; patient celiac or superior mesenteric artery - Aorta diameter greater than or equal to 11mm at the target crossing site - Concordance of the study eleigibility committee EXCLUSION CRITERIA: - High risk features on baseline CT including porcelain aorta (confluent calcification); pedunculated aortic atheroma; or leftward aortic angel greater than or equal to 20 degrees with regard to vertical. - Renal dysfunction limiting follow-up contrast-enhanced CR (estimated glomerular filtration rate, eGFR less than 30mL/min/1.73m^2 if not already on renal replacement therapy) - Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert J Lederman, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03432494
Organization ID
999918045
Secondary IDs
18-H-N045
Responsible Party
Sponsor
Study Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor
Robert J Lederman, M.D., Principal Investigator, National Heart, Lung, and Blood Institute (NHLBI)
Verification Date
June 2020