The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
Primary Purpose
Mitral Valve Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Half Moon TMVr System
Sponsored by
About this trial
This is an interventional device feasibility trial for Mitral Valve Insufficiency
Eligibility Criteria
Key Inclusion Criteria:
- 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
- Native mitral valve geometry and size compatible with the Half Moon TMVr implant
- Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
- Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits
Key Exclusion Criteria:
- 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
- Diseased mitral anterior leaflet such as flail or prolapse
- 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
- Left ventricular end diastolic diameter (LVEDD) > 75mm
- Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure
- Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
- Severe tricuspid regurgitation
- Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
- Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
- Prior stroke, TIA, or myocardial infarction within 90 days
- Need for coronary revascularization
- Severe symptomatic carotid artery stenosis
- Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc
- Need for emergent surgery
- Endocarditis within 6 months
- Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment
- GI bleeding within 6 months
- History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion
- Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support
- Platelet count of <75,000 cells/mm3
- Renal insufficiency (Creatinine > 2.5 mg/dL)
- Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)
- Contraindication to transesophageal echocardiography (TEE)
- Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically
- Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)
- Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint
Sites / Locations
- Columbia University Medical Center/NewYork Presbyterian HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Half Moon TMVr System
Arm Description
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.
Outcomes
Primary Outcome Measures
Adverse Events
Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device
Secondary Outcome Measures
Device Placement
Assessment of the ability to accurately deliver and place the implant within the native anatomy
Device Performance
The degree of improvement of MR grade
Symptom Improvement
The degree of improvement of MR symptoms
Device Durability
The durability of TMVr function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04343313
Brief Title
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Half Moon Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Half Moon TMVr System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Half Moon TMVr System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Device Placement
Description
Assessment of the ability to accurately deliver and place the implant within the native anatomy
Time Frame
30 Days (+ annually through 5 years)
Title
Device Performance
Description
The degree of improvement of MR grade
Time Frame
30 Days (+ annually through 5 years)
Title
Symptom Improvement
Description
The degree of improvement of MR symptoms
Time Frame
30 Days (+ annually through 5 years)
Title
Device Durability
Description
The durability of TMVr function
Time Frame
30 Days (+ annually through 5 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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
Native mitral valve geometry and size compatible with the Half Moon TMVr implant
Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits
Key Exclusion Criteria:
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
Diseased mitral anterior leaflet such as flail or prolapse
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
Left ventricular end diastolic diameter (LVEDD) > 75mm
Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure
Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
Severe tricuspid regurgitation
Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
Prior stroke, TIA, or myocardial infarction within 90 days
Need for coronary revascularization
Severe symptomatic carotid artery stenosis
Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc
Need for emergent surgery
Endocarditis within 6 months
Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment
GI bleeding within 6 months
History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion
Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support
Platelet count of <75,000 cells/mm3
Renal insufficiency (Creatinine > 2.5 mg/dL)
Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)
Contraindication to transesophageal echocardiography (TEE)
Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically
Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)
Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Straley
Phone
4153109197
Email
craigstraley.halfmoon@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Romil Rambhia
Email
rrambhia@thefoundry.com
Facility Information:
Facility Name
Columbia University Medical Center/NewYork Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susheel Kodali, MD
Email
sk2427@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Kate Dalton
Email
keb2114@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Susheel Kodali, MD
12. IPD Sharing Statement
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The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
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