Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access

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
National Heart, Lung, and Blood Institute (NHLBI)

501 total trials

What the finished NCT02280824 record still lists

NCT02280824 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 1,037-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (83% lower).

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 lists 15 locations in 10 states (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.

Learn More About Clinical Trials

Similar trials for Aortic Valve Stenosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02280824's enrollment target sits among peer trials

172 18th of 30 higher than 13 of 30 other Aortic Valve Stenosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Aortic Valve Stenosis 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04801797 · 172 participants · Phase 2

    Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

  • NCT04867317 · 172 participants · Phase 3

    Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

  • NCT05357040 · 172 participants · Phase 2

    Antidepressant Effects of Nitrous Oxide

  • NCT05587517 · 172 participants · Phase 2

    A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT02280824, the US trial registry maintained by the National Library of Medicine. NCT02280824 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.