Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access
Public ClinicalTrials.gov record NCT02280824. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02280824
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 172 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2014
- Primary completion
- Jul 26, 2017
- Completion
- Dec 27, 2018
- Last update posted
- Feb 14, 2019
2014 – 2018
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Emory University | Atlanta | Georgia | 30322-1102 | — |
| NorthShore University HealthSystem, Evanston Hospital | Evanston | Illinois | 60201 | — |
| Advocate Heart Institute | Oakbrook Terrace | Illinois | 60181 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| Ochsner Health System | New Orleans | Louisiana | 70121 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Wake Forest University | Winston-Salem | North Carolina | 27103 | — |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | — |
| York Hospital | York | Pennsylvania | 17403 | — |
| Vanderbilt Heart and Vascular Institute | Nashville | Tennessee | 37232 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| INOVA Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Carilion Medical Center | Roanoke | Virginia | 24014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02280824, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 14, 2019 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02280824 live on ClinicalTrials.gov.