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NCT04375332 · ClinicalTrials.gov registry record · NA

Beating Heart Mitral Valve Repair With the HARPOON™ System

A NA study of Mitral Regurgitation, sponsored by Edwards Lifesciences.

Active
Registry status
NA
Development phase
25
Enrollment target
9
Study locations

NCT04375332 is a NA study of Mitral Regurgitation that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 25 participants, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT04375332, a NA study of Mitral Regurgitation, is active but no longer recruiting, sponsored by Edwards Lifesciences.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
25 participants
Enrollment target
9
Study locations

Study Summary

The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).

Conditions Studied

Mitral Regurgitation

Interventions

  • DEVICE HARPOON™ Beating Heart Mitral Valve Repair System

Study Locations (9)

Maryland

  • University of Maryland Medical Center - Baltimore
  • Johns Hopkins - Baltimore

California

  • UCSF - San Francisco

Georgia

  • Piedmont Heart Institute - Atlanta

Michigan

  • University of Michigan Health System - Ann Arbor

Minnesota

  • Mayo Clinic - Rochester

Oregon

  • OHSU Knight Cardiovascular Institute - Portland

Tennessee

  • Centennial Medical Center - Nashville

Utah

  • Intermountain Heart Institute - Murray

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-12-16
Est. Completion 2027-12-20
Phase NA

Sponsor

Edwards Lifesciences

57 total trials

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What the Registry Record Tells You About NCT04375332

The ClinicalTrials.gov registry entry for NCT04375332 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (98% lower). The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which HARPOON™ Beating Heart Mitral Valve Repair System is the first listed.

NCT04375332 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Maryland, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT04375332 about?

NCT04375332 is a clinical study titled "Beating Heart Mitral Valve Repair With the HARPOON™ System". The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).

What is the current status of trial NCT04375332?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2020-12-16. Estimated completion is 2027-12-20.

What conditions does trial NCT04375332 study?

This clinical trial studies the following conditions: Mitral Regurgitation.

What interventions are being tested in trial NCT04375332?

The interventions under investigation include: HARPOON™ Beating Heart Mitral Valve Repair System (DEVICE).

Who is sponsoring clinical trial NCT04375332?

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

Where is trial NCT04375332 being conducted?

This trial has 9 study locations across California, Georgia, Maryland, Michigan, Minnesota. 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.