Half Moon TMVr System for Mitral Valve Regurgitation

Phase-Based Progress Estimates
Columbia University Medical Center/NewYork Presbyterian Hospital, New York, NYMitral Valve RegurgitationHalf Moon TMVr System - Device
21 - 95
All Sexes
What conditions do you have?

Study Summary

This trial is to study a new mitral valve repair system in patients who are at high risk for conventional mitral valve surgery.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 30 Days (+ annually through 5 years)

30 Days
Adverse Events
Year 5
Device Durability
Device Performance
Device Placement
Symptom Improvement

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Half Moon TMVr System
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Half Moon TMVr System · No Placebo Group · N/A

Half Moon TMVr System
Experimental Group · 1 Intervention: Half Moon TMVr System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days (+ annually through 5 years)

Who is running the clinical trial?

Half Moon MedicalLead Sponsor

Eligibility Criteria

Age 21 - 95 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a heart condition called mitral regurgitation, and you are experiencing symptoms despite receiving the recommended medical treatment.
Your heart's mitral valve must be the right size and shape to fit the Half Moon TMVr implant.
Your heart's anatomy is suitable for the Half Moon TMVr System to be inserted through the femoral vein.

Frequently Asked Questions

To whom is enrollment in this clinical experiment available?

"Eligibility requirements to join this trial include having a diagnosis of mitral valve insufficiency and being between 21-95 years old. Currently, the research team is seeking 30 participants in total." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment size of this research trial?

"Affirmative. Clinicaltrials.gov reports that this study, which was first posted on December 8th 2020, is actively seeking participants. 30 individuals are required to be recruited from only one medical centre." - Anonymous Online Contributor

Unverified Answer

Is this clinical investigation open to participants who are of legal age?

"Eligibility for this trial is determined by the patient's age, with those over 21 and less than 95 years old being able to participate." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities for individuals to participate in this research project?

"Information hosted on clinicaltrials.gov confirms that this healthcare trial is still allocating participants. The study was initially posted on December 8th 2020 and the data was most recently modified on March 15th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.