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NCT03523416 · ClinicalTrials.gov registry record · NA

Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

A NA study of Heart Failure, sponsored by Edwards Lifesciences.

Active
Registry status
NA
Development phase
71
Enrollment target
15
Study locations

NCT03523416 is a NA study of Heart Failure that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 71 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 12 states.

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The verdict

NCT03523416, a NA study of Heart Failure, is active but no longer recruiting, sponsored by Edwards Lifesciences.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
71 participants
Enrollment target
15
Study locations

Study Summary

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Conditions Studied

Interventions

  • DEVICE Transcatheter Atrial Shunt System

Study Locations (15)

California

  • UC San Diego Health - La Jolla
  • University California San Francisco - San Francisco

Minnesota

  • Abbott Northwestern - Minneapolis
  • Mayo Clinic - Rochester

Ohio

  • The Christ Hospital - Cincinnati
  • The Ohio State University Medical Center - Columbus

Florida

  • University of Florida Health - Jacksonville - Jacksonville

Indiana

  • St. Vincent Medical Group - Indianapolis

Kansas

  • Kansas University Medical Center - Kansas City

New York

  • Montefiore Medical Center - The Bronx

North Carolina

  • Atrium Health - Charlotte

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2018-07-31
Est. Completion 2028-11
Phase NA

Sponsor

Edwards Lifesciences

57 total trials

What the Registry Record Tells You About NCT03523416

The ClinicalTrials.gov registry entry for NCT03523416 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Transcatheter Atrial Shunt System is the first listed.

NCT03523416 reports 15 study locations spanning 12 distinct geographic areas - top geographies include California, Minnesota, Ohio.

Frequently Asked Questions

What is clinical trial NCT03523416 about?

NCT03523416 is a clinical study titled "Early Feasibility Study - Edwards APTURE Transcatheter Shunt System". The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

What is the current status of trial NCT03523416?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 71 participants. The study started on 2018-07-31. Estimated completion is 2028-11.

What conditions does trial NCT03523416 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT03523416?

The interventions under investigation include: Transcatheter Atrial Shunt System (DEVICE).

Who is sponsoring clinical trial NCT03523416?

This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03523416 being conducted?

This trial has 15 study locations across California, Florida, Indiana, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Heart Failure

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.