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NCT03230747 · ClinicalTrials.gov registry record · NA

SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

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

Active
Registry status
NA
Development phase
72
Enrollment target
9
Study locations

NCT03230747 is a NA study of Mitral Regurgitation and Mitral Disease that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 72 participants, below the 1,021-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (93% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT03230747, a NA study of Mitral Regurgitation and Mitral Disease, is active but no longer recruiting, sponsored by Edwards Lifesciences.

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

Study Summary

This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.

Interventions

  • DEVICE Edwards SAPIEN M3 System

Study Locations (9)

California

  • Cedars-Sinai Medical Center Heart Institute - Los Angeles
  • California Pacific Medical Center - San Francisco

Georgia

  • Emory University - Atlanta

Illinois

  • Evanston/ Northshore University - Evanston

Michigan

  • Henry Ford Hospital - Detroit

Minnesota

  • Mayo Clinic - Rochester

Utah

  • Intermountain Medical Center - Murray

Virginia

  • Sentara Cardiovascular Research Institution - Norfolk

British Columbia

  • St. Paul's Hospital - Vancouver

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2017-09-14
Est. Completion 2027-08
Phase NA

Sponsor

Edwards Lifesciences

57 total trials

What the Registry Record Tells You About NCT03230747

The ClinicalTrials.gov registry entry for NCT03230747 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,021-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (93% lower). The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Edwards SAPIEN M3 System is the first listed.

NCT03230747 reports 9 study locations spanning 8 distinct geographic areas - top geographies include California, Georgia, Illinois.

Frequently Asked Questions

What is clinical trial NCT03230747 about?

NCT03230747 is a clinical study titled "SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation". This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.

What is the current status of trial NCT03230747?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2017-09-14. Estimated completion is 2027-08.

What conditions does trial NCT03230747 study?

This clinical trial studies the following conditions: Mitral Regurgitation, Mitral Disease.

What interventions are being tested in trial NCT03230747?

The interventions under investigation include: Edwards SAPIEN M3 System (DEVICE).

Who is sponsoring clinical trial NCT03230747?

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

Where is trial NCT03230747 being conducted?

This trial has 9 study locations across California, Georgia, Illinois, 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.