Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access
NCT ID: NCT02280824
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
172 participants
INTERVENTIONAL
2014-10-30
2018-12-28
Brief Summary
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\- Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. For this technique, doctors make a hole between the largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they replace the valve through a tube they put in the groin vein. Then they close the hole between the vein and the artery using a device designed to close holes in the heart. This study tests the device for this new, off-label use.
Objective:
\- To further study the safety and effectiveness of transcaval TAVR.
Eligibility:
\- Adults age 21 and older who would benefit from TAVR but for whom standard techniques are not suitable.
Design:
* Participants will be selected by a team of heart specialists and others.
* Participants will have a computed tomography (CT) scan with or without contrast dye.
* Participants will have blood tests.
* Participants will have transcaval TAVR.
* Participants will receive the same standard care as for all patients with TAVR.
* Participants will also have another CT scan, or an MRI or ultrasound, before they leave the hospital, and again after about 30 days and after about 12 months.
* Participants will be contacted 1 and 6 months afterwards and will have another visit 1 year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a physical exam.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access
CA-TAVR
Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access
Amplatzer Duct Occluder
Interventions
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CA-TAVR
Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access
Amplatzer Duct Occluder
Eligibility Criteria
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Inclusion Criteria
* Severe symptomatic de novo aortic valve stenosis or bioprosthetic aortic valve failure for which transcatheter aortic valve replacement (TAVR) is felt beneficial according to the consensus of the institutional multidisciplinary heart team
* Extreme risk or inoperability for TAVR via conventional femoral artery, trans-apical, or trans-aortic access in the determination of the multidisciplinary heart team. This determination includes an in-person consultation by at least one cardiac surgeon member of the heart team.
* Anatomic eligibility for caval-aortic TAVR, graded as favorable or feasible based on NHLBI core lab assessment of the baseline CT examination.
Exclusion Criteria
* Anatomic eligibility for caval-aortic TAVR graded as unfavorable based on NHLBI core lab assessment of the baseline CT examination
* Unlikely to benefit from caval-aortic TAVR
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
21 Years
99 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Robert J Lederman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
NorthShore University HealthSystem, Evanston Hospital
Evanston, Illinois, United States
Advocate Heart Institute
Oakbrook Terrace, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Ochsner Health System
New Orleans, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
York Hospital
York, Pennsylvania, United States
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
INOVA Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Carilion Medical Center
Roanoke, Virginia, United States
Countries
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References
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Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
Greenbaum AB, O'Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, Lederman RJ. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2795-804. doi: 10.1016/j.jacc.2014.04.015. Epub 2014 May 7.
Halabi M, Ratnayaka K, Faranesh AZ, Chen MY, Schenke WH, Lederman RJ. Aortic access from the vena cava for large caliber transcatheter cardiovascular interventions: pre-clinical validation. J Am Coll Cardiol. 2013 Apr 23;61(16):1745-6. doi: 10.1016/j.jacc.2013.01.057. Epub 2013 Apr 2. No abstract available.
Lederman RJ, Babaliaros VC, Rogers T, Stine AM, Chen MY, Muhammad KI, Leonardi RA, Paone G, Khan JM, Leshnower BG, Thourani VH, Tian X, Greenbaum AB. The Fate of Transcaval Access Tracts: 12-Month Results of the Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):448-456. doi: 10.1016/j.jcin.2018.11.035.
Greenbaum AB, Babaliaros VC, Chen MY, Stine AM, Rogers T, O'Neill WW, Paone G, Thourani VH, Muhammad KI, Leonardi RA, Ramee S, Troendle JF, Lederman RJ. Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation. J Am Coll Cardiol. 2017 Feb 7;69(5):511-521. doi: 10.1016/j.jacc.2016.10.024. Epub 2016 Oct 29.
Other Identifiers
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15-H-N009
Identifier Type: -
Identifier Source: secondary_id
999915009
Identifier Type: -
Identifier Source: org_study_id
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