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Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access
NCT02280824 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE CA-TAVR
- DEVICE Amplatzer Duct Occluder
Study Locations (15)
Virginia
- University of Virginia Medical Center — Charlottesville
- INOVA Fairfax Hospital — Falls Church
- Sentara Norfolk General Hospital — Norfolk
- Carilion Medical Center — Roanoke
Illinois
- NorthShore University HealthSystem, Evanston Hospital — Evanston
- Advocate Heart Institute — Oakbrook Terrace
Louisiana
- Cardiovascular Institute of the South — Houma
- Ochsner Health System — New Orleans
District of Columbia
- Medstar Washington Hospital Center — Washington D.C.
Georgia
- Emory University — Atlanta
Michigan
- Henry Ford Hospital — Detroit
North Carolina
- Wake Forest University — Winston-Salem
Oklahoma
- Oklahoma Heart Institute — Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2014-10-30 |
| Est. Completion | 2018-12-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02280824
The ClinicalTrials.gov registry entry for NCT02280824 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 381 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions — of which CA-TAVR is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02280824 reports 15 study locations spanning 10 distinct geographic areas — top geographies include Virginia, Illinois, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02280824 about?
NCT02280824 is a clinical study titled "Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access". 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...
What is the current status of trial NCT02280824?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 172 participants. The study started on 2014-10-30. Estimated completion is 2018-12-28.
What conditions does trial NCT02280824 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02280824?
The interventions under investigation include: CA-TAVR (PROCEDURE), Amplatzer Duct Occluder (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02280824?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 381 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02280824 being conducted?
This trial has 15 study locations across District of Columbia, Georgia, Illinois, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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