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

• ClinicalTrials.gov Identifier: NCT03432494
• Recruitment Status: Suspended
• First Posted: February 14, 2018
• Last Update Posted: March 4, 2022
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aortic Stenosis	Device: Transcaval closure device (TCD)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: November 4, 2022
• Estimated Study Completion Date: December 30, 2022

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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)

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, District of Columbia

MedStar Washington Hospital Center

Washington, District of Columbia, United States, 20010

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Michigan

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Robert J Lederman, M.D.; National Heart, Lung, and Blood Institute (NHLBI)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rogers T, Greenbaum AB, Babaliaros VC, Stine AM, Khan JM, Schenke WH, Eng MH, Paone G, Leshnower BG, Satler LF, Waksman R, Chen MY, Lederman RJ. Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing. JACC Cardiovasc Interv. 2019 Nov 11;12(21):2198-2206. doi: 10.1016/j.jcin.2019.05.053. Epub 2019 Oct 16.

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT03432494
• Other Study ID Numbers: 999918045; 18-H-N045
• First Posted: February 14, 2018
• Last Update Posted: March 4, 2022
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

Transcather; Transcaval; Bioprosthesis; Closure Device; Aortic Stenosis

Additional relevant MeSH terms:

Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction