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NCT05686317 · ClinicalTrials.gov registry record · NA

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System

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

Active
Registry status
NA
Development phase
100
Enrollment target
20
Study locations

NCT05686317 is a NA study of Heart Failure that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 100 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT05686317, a NA study of Heart Failure, is active but no longer recruiting, sponsored by Edwards Lifesciences.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
20
Study locations

Study Summary

This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.

Conditions Studied

Interventions

  • DEVICE Edwards APTURE transcatheter shunt system
  • DIAGNOSTIC_TEST Sham procedure

Study Locations (20)

California

  • University of California Irvine - Irvine
  • University of California San Diego - La Jolla
  • Scripps Health - La Jolla
  • University of Southern California - Los Angeles
  • University of California San Francisco - San Francisco

Minnesota

  • Abbott Northwestern Hospital - Minneapolis
  • Mayo Clinic - Rochester

New York

  • St. Francis Hospital & Heart Center - Roslyn
  • Montefiore Medical Center - The Bronx

Ohio

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

Illinois

  • Ascension Illinois Heart and Vascular Medical Group - Elk Grove

Kansas

  • Kansas University Medical Center - Kansas City

Oklahoma

  • Oklahoma Heart Institute - Tulsa

Oregon

  • Oregon Health and Science University - Oregon City

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-04-01
Est. Completion 2030-08-31
Phase NA

Sponsor

Edwards Lifesciences

57 total trials

What the Registry Record Tells You About NCT05686317

The ClinicalTrials.gov registry entry for NCT05686317 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 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 (95% 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 2 interventions - of which Edwards APTURE transcatheter shunt system is the first listed.

NCT05686317 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Minnesota, New York.

Frequently Asked Questions

What is clinical trial NCT05686317 about?

NCT05686317 is a clinical study titled "ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System". This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.

What is the current status of trial NCT05686317?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-04-01. Estimated completion is 2030-08-31.

What conditions does trial NCT05686317 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT05686317?

The interventions under investigation include: Edwards APTURE transcatheter shunt system (DEVICE), Sham procedure (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05686317?

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

Where is trial NCT05686317 being conducted?

This trial has 20 study locations across California, Illinois, Kansas, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.