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Status:

TERMINATED

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

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Aortic Stenosis

Eligibility:

All Genders

21+ years

Phase:

NA

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 thr...

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. Current...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 7 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 29 2019

    Estimated Enrollment :

    12 Patients enrolled

    Trial Details

    Trial ID

    NCT03432494

    Start Date

    February 7 2018

    End Date

    April 29 2019

    Last Update

    March 14 2023

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    MedStar Washington Hospital Center

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

    2

    Emory University

    Atlanta, Georgia, United States, 30322

    3

    Henry Ford Hospital

    Detroit, Michigan, United States, 48202