Health TrialsbyHealthPanel

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

ConditionMitral Valve Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-95
SponsorHalf Moon Medical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+)

Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team

Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies

Age ≥ 21

Disqualifiers

Prior transseptal intervention with occlusion device currently implanted

Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system

Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation

Prohibitive mitral annular or leaflet calcification

Trial design

Design model

Single group

Treatments tested in this trial

  • Half Moon TMVr System

    Device

    The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Half Moon TMVr SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events

Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device

Time frame
30 Days

Secondary outcomes

1

Device Placement

Assessment of the ability to accurately deliver and place the implant within the native anatomy

Time frame
30 Days (+ annually through 5 years)
2

Device Performance

The degree of improvement of MR grade

Time frame
30 Days (+ annually through 5 years)
3

Symptom Improvement

The degree of improvement of MR symptoms

Time frame
30 Days (+ annually through 5 years)
4

Device Durability

The durability of TMVr function

Time frame
30 Days (+ annually through 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Half Moon Medical

Lead sponsor

Source ClinicalTrials.gov
Apply now