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

Status:	Suspended
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	21 - Any
Updated:	1/3/2019
Start Date:	February 7, 2018
End Date:	December 31, 2020

Early Feasibility Evaluation of Transmural Systems Transcaval Closure Device (TCD) for Transcaval Access Ports During Transcatheter Aortic Valve Replacement (TAVR)

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.

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.

- 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

We found this trial at

sites

Emory University

201 Dowman Dr
Atlanta, Georgia 30303

(404) 727-6123