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Device

Transcaval access and closure with the transcaval closure device (TCD) test article. for Aortic Stenosis

N/A
Waitlist Available
Led By Robert J Lederman, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30, 12 months
Awards & highlights

Study Summary

This trialis testing a new way to do TAVR, a common heart procedure, safely for people for whom the standard artery approach isn't safe.

Eligible Conditions
  • Aortic Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)
Secondary outcome measures
All-Cause Mortality
Number of Participants Enrolled Greater Than 65 Years
Number of Participants Final Acute Aorto-caval Fistula Score
+15 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transcaval access and closure with the transcaval closure device (TCD) test article.Experimental Treatment1 Intervention
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,836 Previous Clinical Trials
47,850,845 Total Patients Enrolled
Robert J Lederman, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
12 Previous Clinical Trials
833 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment presently recruiting participants?

"No, regrettably the clinicaltrials.gov database indicates that this trial is not recruiting at present. It was initially posted on February 7th 2018 and last amended on October 28th 2022; nonetheless, there are 161 other medical studies actively accepting patients right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
2018. "Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03432494.
~2 spots leftby Apr 2025
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