Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access

Aortic Valve Stenosis Clinical Trial

Official title:

Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280824
• Other study ID #: 999915009
• Secondary ID: 15-H-N009
• Status: Completed
• Phase: Phase 1
• Start date: October 30, 2014
• Est. completion date: December 28, 2018

Study information

• Verified date: December 28, 2018
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) has enabled transcatheter aortic valve replacement (TAVR) in a small number of patients who have no good options for standard percutaneous femoral access or for standard surgical access to the cardiac apex or to the ascending aorta. In this prospective registry we will collect data from multiple medical centers as they offer transcaval TAVR to patients with extreme or prohibitive risk of conventional TAVR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: December 28, 2018
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

• INCLUSION CRITERIA:

• 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.

EXCLUSION CRITERIA:

• 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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• CA-TAVR
Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access

Device:
• Amplatzer Duct Occluder

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Henry Ford Hospital	Detroit	Michigan
United States	NorthShore University HealthSystem, Evanston Hospital	Evanston	Illinois
United States	INOVA Fairfax Hospital	Falls Church	Virginia
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee
United States	Ochsner Health System	New Orleans	Louisiana
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Advocate Heart Institute	Oakbrook Terrace	Illinois
United States	Carilion Medical Center	Roanoke	Virginia
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest University	Winston-Salem	North Carolina
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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