Mitral Valve Regurgitation (Degenerative or Functional)MARCHNCT07188233
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
A study testing Transcatheter Mitral Valve Repair in people with Mitral Valve Regurgitation (Degenerative or Functional), run by HVR Cardio Oy at 2 sites in 2 countries.
Trial summary
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation (Degenerative or Functional)
- What is being tested?
- Transcatheter Mitral Valve Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Nov 2024to Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe (3+) or severe (4+) functional mitral regurgitation
- Left ventricular ejection fraction ≥30%
- Symptomatic New York Heart Association (NYHA) Class II to IV).
Who cannot join
- Oxygen dependent for COPD
- Active or suspected endocarditis
- Severe symptomatic carotid stenosis
- Has undergone heart transplantation.
- Severe calcification of the mitral annulus or leaflets
- Coronary sinus anatomy that may preclude proper treatment with the device
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Georgia1 site, 1 recruiting
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Tamaz Shaburishvili
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital, Santaros Klinikos, Public Institution
Vilnius, Lithuania
Giedrius Davidavičius
About this study
Official title: A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.
- Being tested
- Transcatheter Mitral Valve Repair
- 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.
Transcatheter Mitral Valve RepairDevice
Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Not described Receives: Device: Transcatheter Mitral Valve Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).
Technical Device Success: MVARC Technical Success is a definition from the Mitral Valve Academic Research Consortium for evaluating transcatheter mitral valve interventions, defined at the exit from the procedure room and requires all of the following conditions to be met:
- The patient is alive.
- There was successful access, delivery, and retrieval of the device delivery system.
- The first intended device was successfully deployed and correctly positioned.
- There was freedom from emergency surgery or reintervention related to the device or access procedure.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start16 Nov 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve Regurgitation (Degenerative or Functional)Studies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HVR Cardio Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinayak Bapat, Principal investigator, Abbott Northwestern and United Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188233
- Sponsor's protocol ID
- CIP-2023-008
- Acronym
- MARCH
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT07188233
- Acronym / sponsor ID
- MARCH / CIP-2023-008
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- HVR Cardio OyIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Sep 2025 (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.
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Transcatheter Mitral Valve Repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe (3+) or severe (4+) functional mitral regurgitation
- Left ventricular ejection fraction ≥30%
- Symptomatic New York Heart Association (NYHA) Class II to IV).
Key exclusion criteria (6 listed)
- Oxygen dependent for COPD
- Active or suspected endocarditis
- Severe symptomatic carotid stenosis
- Has undergone heart transplantation.
- Severe calcification of the mitral annulus or leaflets
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 |
|---|---|---|
| Transcatheter Mitral Valve RepairMitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation | Device | Single Arm |
Primary outcome
Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).
Time frame: Periprocedural
Technical Device Success: MVARC Technical Success is a definition from the Mitral Valve Academic Research Consortium for evaluating transcatheter mitral valve interventions, defined at the exit from the procedure room and requires all of the following conditions to be met: 1. The patient is alive. 2. There was successful access, delivery, and retrieval of the device delivery system. 3. The first intended device was successfully deployed and correctly positioned. 4. There was freedom from emergency surgery or reintervention related to the device or access procedure.
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 23 Sep 2025.
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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.
Vinayak Bapat principal investigator
Abbott Northwestern and United Hospitals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Mitral Valve Repair in people with Mitral Valve Regurgitation (Degenerative or Functional), run by HVR Cardio Oy at 2 sites in 2 countries.
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 3 inclusion and 6 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia, Lithuania. 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 Thomas Fleming (612 940 8037, tom@hvrcardio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC). (time frame: Periprocedural). 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 23 Sep 2025.