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NCT03432494 · ClinicalTrials.gov registry record · NA
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
A NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT03432494: Clinical Trial NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03432494 is a NA study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03432494, a NA study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Background: Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement. Not all patients are eligible for TAVR using standard access through the artery in the groin, because the artery is too small or too diseased. In this study, TAVR is performed using a new technique called transcaval access. The catheter is placed in the artery deep in the body by crossing through the wall of a deep vein. The connection between that vein and the aorta is closed with a new metallic device they are testing. This is called a transcaval closure device (TCD). Objective: To test the safety and early feasibility of closure of transcaval aortic access sites using the TCD after TAVR. Eligibility: Adults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by the standard artery approach Design: Participants will be assessed by heart experts including cardiologists and surgeons. Participants will have TAVR by the transcaval approach. A small catheter will be passed between the largest vein in the body and the nearby largest artery (aorta), inside the abdomen. Through this catheter, the TAVR will be implanted in the usual way. After, doctors will implant the TCD by catheter to close the hole made in the aorta. Participants will be X-rayed. A dye will be injected to view the TCD device. Participants will get standard TAVR care afterwards. They will have physical exams, blood tests, and scans. Participants will have a follow-up scan within 1 month and after 12 months. Participants will have follow-up visits and phone calls 6 and 12 months after the procedure.
Primary Outcome
Number of participants with technical success of delivery of the transcaval closure device (TCD) All of the following must be present for technical success: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system 5.
Interventions
- DEVICE Transcaval closure device (TCD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-02-07 |
| Est. Completion | 2019-04-29 |
| Phase | NA |
Why NCT03432494 stopped before completion
NCT03432494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Transcaval closure device (TCD) is the first listed.
NCT03432494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03432494 about?
NCT03432494 is a clinical study titled "Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement". Background: Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement. Not all patients are eligible for TAVR using standard access through the artery in the groin, because the artery is too small or too diseased. In this study, TAVR i...
What is the current status of trial NCT03432494?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2018-02-07. Estimated completion is 2019-04-29.
What interventions are being tested in trial NCT03432494?
The interventions under investigation include: Transcaval closure device (TCD) (DEVICE).
Who is sponsoring clinical trial NCT03432494?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03432494's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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