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

NCT03432494 | Terminated Results FDA Device

• 2 other identifiers: 99991804518-H-N045
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Aortic Stenosis

Keywords

Transcatheter; Transcaval; Bioprosthesis; Closure Device; Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)

  Number of participants with technical success of delivery of the transcaval closure device (TCD) All of the following must be present for technical success: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system 5. Adjunctive balloon aortic tamponade is permissible and consistent with technical success

  1 minute following procedure discharge (Exit from the catheterization laboratory)

Secondary Outcomes (18)

• Number of Participants With Closure Success of the Transcaval Closure Device (TCD)

  1 minute following procedure discharge (Exit from the catheterization laboratory)

• Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)

  30 days and 12 Months

• Number of Participants That Experienced Procedural Success

  30 Days

• Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure

  During procedure, procedure may last from 2 to 4 hours

• Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site

  During procedure, procedure may last from 2 to 4 hours

Study Arms (1)

Transcaval access and closure with the transcaval closure device (TCD) test article.

EXPERIMENTAL

All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).

Device: Transcaval closure device (TCD)

Interventions

Transcaval closure device (TCD) DEVICE

Transcaval access and closure using the Transmural Transcaval Closure Device (TCD) at the time of medically-necessary transcatheter aortic valve replacement (TAVR).

Transcaval access and closure with the transcaval closure device (TCD) test article.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Evolut 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 eligibility committee

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (3)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 31629746 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The clinical trial was put suspended due to device needing to be redesign however funding never materialized to support the redesign, therefore, clinical trials was terminated early.

Results Point of Contact

• Title: Dr. Robert Lederman, Principal Investigator
• Organization: National Heart, Lung, and Blood Institute (NHLBI)

ledermar@nhlbi.nih.gov

301.402.6769

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 14, 2018
• Study Start: February 7, 2018
• Primary Completion: April 30, 2018
• Study Completion: April 29, 2019
• Last Updated: March 14, 2023
• Results First Posted: March 14, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)