NCT02280824

Brief Summary

Background: \- 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_1

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

February 15, 2019

Status Verified

December 28, 2018

Enrollment Period

2.7 years

First QC Date

October 30, 2014

Last Update Submit

February 13, 2019

Conditions

Aortic Valve Stenosis

Keywords

TranscavalTAVRAMPLATZER(R) Occluder

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access

    The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access

    1 year

Study Arms (1)

A

EXPERIMENTAL

Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access

Procedure: CA-TAVRDevice: Amplatzer Duct Occluder

Interventions

CA-TAVRPROCEDURE

Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access

A
Amplatzer Duct OccluderDEVICE
A

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age greater than or equal to 21 years
  • 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.

You may not qualify if:

  • Unable or unwilling to consent to participate
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Medstar Washington Hospital Center

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

Location

Emory University

Atlanta, Georgia, 30322-1102, United States

Location

NorthShore University HealthSystem, Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Advocate Heart Institute

Oakbrook Terrace, Illinois, 60181, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27103, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37232, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24014, United States

Location

Related Publications (6)

  • 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.

    PMID: 20961243BACKGROUND

  • 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.

    PMID: 21639811BACKGROUND

  • 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.

    PMID: 24814495BACKGROUND

  • 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.

    PMID: 23500317BACKGROUND

  • 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.

    PMID: 30846083DERIVED

  • 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.

    PMID: 27989885DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Robert J Lederman, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 3, 2014

Study Start

October 30, 2014

Primary Completion

July 27, 2017

Study Completion

December 28, 2018

Last Updated

February 15, 2019

Record last verified: 2018-12-28

Locations

US(15)