Mitral Valve InsufficiencyNCT04343313
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
A study testing Half Moon TMVr System in people with Mitral Valve Insufficiency, run by Half Moon Medical at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Half Moon TMVr System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Dec 2020to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Romil Rambhia contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Guilherme Attizzani, MD
- Recruiting
UPMC Heart & Vascular Institute
Harrisburg, Pennsylvania, 17104
Hemal Gada, MD
- Recruiting
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032
Susheel Kodali, MD, sk2427@cumc.columbia.edu
Kate Dalton, keb2114@cumc.columbia.edu
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Firas Zahr, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Azeem Latib, MD
About this 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
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
- Mitral Valve Insufficiency
- Being tested
- Half Moon TMVr System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Half Moon TMVr SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Half Moon TMVr System | Experimental | 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. Receives: Device: Half Moon TMVr System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device
Measured: 30 Days
Secondary outcomes (4)
Device Placement
Assessment of the ability to accurately deliver and place the implant within the native anatomy
Measured: 30 Days (+ annually through 5 years)
Device Performance
The degree of improvement of MR grade
Measured: 30 Days (+ annually through 5 years)
Symptom Improvement
The degree of improvement of MR symptoms
Measured: 30 Days (+ annually through 5 years)
Device Durability
The durability of TMVr function
Measured: 30 Days (+ annually through 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start8 Dec 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Half Moon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343313
- Sponsor's protocol ID
- CIP-0001
- Status last verified
- Jan 2024
- First submitted
- 9 Apr 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04343313
- Acronym / sponsor ID
- CIP-0001
- Conditions
- Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Half Moon MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Half Moon TMVr System | Experimental | Device: Half Moon TMVr SystemThe 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. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Half Moon TMVr SystemThe 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. | Device | Half Moon TMVr System |
Primary outcome
Adverse Events
Time frame: 30 Days
Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device
4 secondary outcomes
Device Placement
Time frame: 30 Days (+ annually through 5 years)
Device Performance
Time frame: 30 Days (+ annually through 5 years)
Symptom Improvement
Time frame: 30 Days (+ annually through 5 years)
Device Durability
Time frame: 30 Days (+ annually through 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romil Rambhia contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Half Moon TMVr System in people with Mitral Valve Insufficiency, run by Half Moon Medical at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig Straley (4153109197, craigstraley.halfmoon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.