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NCT04343313 · ClinicalTrials.gov registry record · NA

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

A NA study of Mitral Valve Insufficiency, sponsored by Half Moon Medical.

Recruiting
Registry status
NA
Development phase
30
Enrollment target
5
Study locations

NCT04343313 is a NA study of Mitral Valve Insufficiency that is actively recruiting participants, run by Half Moon Medical. The registered enrollment target is 30 participants, below the 383-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT04343313, a NA study of Mitral Valve Insufficiency, is actively recruiting participants, sponsored by Half Moon Medical.

RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
5
Study locations

Study Summary

The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

Conditions Studied

Interventions

  • DEVICE Half Moon TMVr System

Study Locations (5)

New York

  • Columbia University Medical Center/NewYork Presbyterian Hospital - New York
  • Montefiore Medical Center - The Bronx

Ohio

  • University Hospitals Cleveland Medical Center - Cleveland

Oregon

  • Oregon Health & Science University - Portland

Pennsylvania

  • UPMC Heart & Vascular Institute - Harrisburg

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2020-12-08
Est. Completion 2029-12-31
Phase NA

Sponsor

Half Moon Medical

1 total trials

What the Registry Record Tells You About NCT04343313

The ClinicalTrials.gov registry entry for NCT04343313 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 383-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (92% lower). The listed sponsor is Half Moon Medical, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Mitral Valve Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Half Moon TMVr System is the first listed.

NCT04343313 reports 5 study locations spanning 4 distinct geographic areas - top geographies include New York, Ohio, Oregon.

Frequently Asked Questions

What is clinical trial NCT04343313 about?

NCT04343313 is a clinical study titled "The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study". The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

What is the current status of trial NCT04343313?

This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2020-12-08. Estimated completion is 2029-12-31.

What conditions does trial NCT04343313 study?

This clinical trial studies the following conditions: Mitral Valve Insufficiency.

What interventions are being tested in trial NCT04343313?

The interventions under investigation include: Half Moon TMVr System (DEVICE).

Who is sponsoring clinical trial NCT04343313?

This trial is sponsored by Half Moon Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04343313 being conducted?

This trial has 5 study locations across New York, Ohio, Oregon, Pennsylvania. 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

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