Clinical trial NCT03432494: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Stenosis
Keywords: Transcatheter
Transcaval
Bioprosthesis
Closure Device
Aortic Stenosis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2018-02-14
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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 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

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

Primary outcomes:
measure: Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)
timeFrame: 1 minute following procedure discharge (Exit from the catheterization laboratory)
Secondary outcomes:
measure: Number of Participants With Closure Success of the Transcaval Closure Device (TCD)
timeFrame: 1 minute following procedure discharge (Exit from the catheterization laboratory)
measure: Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)
timeFrame: 30 days and 12 Months
measure: Number of Participants That Experienced Procedural Success
timeFrame: 30 Days
measure: Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure
timeFrame: During procedure, procedure may last from 2 to 4 hours
measure: Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site
timeFrame: During procedure, procedure may last from 2 to 4 hours
measure: Number of Participants Final Acute Aorto-caval Fistula Score
timeFrame: 30 Days
measure: Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications
timeFrame: 30 days
measure: Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications
timeFrame: 30 Days
measure: Number of Participants Who Experienced Major Adverse Cardiovascular Events
timeFrame: Day 30
measure: Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD)
timeFrame: 30 Days and 12 Months
measure: All-Cause Mortality
timeFrame: 30 Days
measure: Number of Participants With Aorto-caval Fistula Patency Assessed by Angiography and Arterial-phase Follow-up Computed Tomography
timeFrame: Day 30, 12 months
measure: Number of Participants Who Experienced Acute Kidney Injury Stage 2 or 3
timeFrame: 30 Days
measure: Number of Participants That Are Free From Infection Related to the Transcaval Closure Device
timeFrame: Day 30, 12 Months
measure: Number of Participants That Experience Thrombocytopenia and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device
timeFrame: 30 Days
measure: Number of Participants Who Experience Hemolysis and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device
timeFrame: 30 Days
measure: Participant Cumulative Computed Tomography Analysis of Device
timeFrame: Day 30
measure: Number of Participants Enrolled Greater Than 65 Years
timeFrame: Enrollment
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Robert J Lederman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.