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

Mitral Valve Insufficiency Clinical Trial

Official title:

Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04343313
• Other study ID #: CIP-0001
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2024
• Source: Half Moon Medical
• Contact: Craig Straley
• Phone: 4153109197
• Email: craigstraley.halfmoon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

Key Inclusion Criteria:

1. Moderately severe or severe mitral regurgitation (MR Grade = 3+)

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

3. 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

4. Age = 21

5. Native mitral valve geometry and size compatible with the Half Moon TMVr implant

6. Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System

7. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits

Key Exclusion Criteria:

1. Prior transseptal intervention with occlusion device currently implanted

2. 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

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

4. Prohibitive mitral annular or leaflet calcification

5. Diseased mitral anterior leaflet such as flail or prolapse

6. Left ventricular ejection fraction (LVEF) < 25%, or LVEF 25-30% in the presence of left ventricular end diastolic volume index (LVEDVi) >120mL/m2 as measured by resting echocardiogram within 30 days of the Index Procedure

7. Left ventricular end diastolic diameter (LVEDD) > 75mm

8. Pulmonary hypertension with resting pulmonary artery systolic pressures = 2/3 systemic systolic pressure

9. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction

10. Severe tricuspid regurgitation

11. Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure

12. Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment

13. Prior stroke, TIA, or myocardial infarction within 90 days

14. Need for coronary revascularization

15. Severe symptomatic carotid artery stenosis

16. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc

17. Need for emergent surgery

18. Endocarditis within 6 months

19. Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment

20. GI bleeding within 6 months

21. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion

22. Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support

23. Platelet count of <75,000 cells/mm3

24. Renal insufficiency (Creatinine > 2.5 mg/dL)

25. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)

26. Contraindication to transesophageal echocardiography (TEE)

27. Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically

28. Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)

29. Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• Half Moon TMVr System
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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	UPMC Heart & Vascular Institute	Harrisburg	Pennsylvania
United States	Columbia University Medical Center/NewYork Presbyterian Hospital	New York	New York
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Half Moon Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device	30 Days
Secondary	Device Placement	Assessment of the ability to accurately deliver and place the implant within the native anatomy	30 Days (+ annually through 5 years)
Secondary	Device Performance	The degree of improvement of MR grade	30 Days (+ annually through 5 years)
Secondary	Symptom Improvement	The degree of improvement of MR symptoms	30 Days (+ annually through 5 years)
Secondary	Device Durability	The durability of TMVr function	30 Days (+ annually through 5 years)