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NCT02280824 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Aortic Valve Stenosis, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Completed
Registry status
Phase 1
Development phase
172
Enrollment target
15
Study locations

NCT02280824 is a Phase 1 study of Aortic Valve Stenosis that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 172 participants, below the 1,037-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (83% lower). The trial reports 15 study locations across 10 states.

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The verdict

NCT02280824, a Phase 1 study of Aortic Valve Stenosis, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

COMPLETED
Registry status
Phase 1
Development phase
172 participants
Enrollment target
15
Study locations

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

Aortic Valve Stenosis

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

FieldValue
Enrollment Target 172 participants
Start Date 2014-10-30
Est. Completion 2018-12-28
Phase Phase 1

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

501 total trials

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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, categorized as Phase 1. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,037-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (83% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.

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.

NCT02280824 reports 15 study locations spanning 10 distinct geographic areas - top geographies include Virginia, Illinois, Louisiana.

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.

What interventions are being tested in trial NCT02280824?

The interventions under investigation include: CA-TAVR (PROCEDURE), Amplatzer Duct Occluder (DEVICE).

Who is sponsoring clinical trial NCT02280824?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

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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