Functional Mitral RegurgitationNCT06583876
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
A study testing Coriofix System in people with Functional Mitral Regurgitation, run by Bio Refine Ltd. at 8 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- Coriofix System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 3 Jun 2024to Apr 2028
- 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
- Local heart team has determined that mitral valve surgery will not be offered as a treatment option
- Symptomatic secondary mitral regurgitation (3+ or 4+)
- Adequately treated in compliance with optimal guideline-directed medical therapy for heart failure for at least 90 days
- NYHA functional class II, III or ambulatory IV
- LVEF ≥30%.
- Written informed consent has been obtained
Who cannot join
- Untreated clinically significant coronary artery disease requiring revascularization.
- CABG, PCI or TAVR within the prior 90 days.
- Aortic or tricuspid valve disease requiring surgery or transcatheter intervention or severe tricuspid regurgitation.
- COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
- CVA or TIA within prior 180 days.
- Hypotension
Show all 13Show fewer
- Any history of ventricular arrythmia
- Patients implanted with any kind of CIED
- Life expectancy <12 months due to non-cardiac conditions
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
- TEE is contraindicated or high risk
- Pregnant or planning pregnancy within next 12 months
- Currently participating in an investigational drug or another device study that has not reached its primary endpoint
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
Poland3 sites, 3 recruiting
- Recruiting
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice
Wojciech Wojakowski, MD, + 48323598000, wojtek.wojakowski@gmail.com
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan
Marek Grygier, MD, + 48618549121, marek.grygier@usk.poznan.pl
- Not yet recruiting
Wojskowy Instytut Medyczny
Warsaw
Michał Zembala MD, PhD Michał Zembala MD, PhD, MD, +48 600 402 994, m.zembala.jr@icloud.com
Hungary2 sites, 2 recruiting
- Recruiting
Gottsegen National Cardiovascular Center
Budapest
Géza Fontos, MD, +36 70 3820358, geza.fontos@gmail.com
- Recruiting
University of Debrecen
Debrecen
Attila Kertész, MD, +36-30-3996248, kertesz@med.unideb.hu
Attila Kertész, MD
Serbia2 sites
- Terminated
Institute for Cardiovascular Diseases "Dedinje"
Belgrade
- Withdrawn
University Clinical Center Kragujevac
Kragujevac
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Leor Perl, MD, +972-3-937-4666, leorper@clalit.org.il
About this study
The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation.
The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive).
Read more
Potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.
Additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- Coriofix System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coriofix SystemDevice
Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.
| Study group | Role | What they receive |
|---|---|---|
| Coriofix treatment | Experimental | Not described Receives: Device: Coriofix System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coriofix System Safety
Absence of Major Device- or Procedure-Related Serious Adverse Events
Measured: 30 days
Secondary outcomes (3)
Coriofix System Safety
Absence of Major Device- or Procedure-Related Serious Adverse Events
Measured: 6 and 12 months
Device technical success
Successful system operation with no related emergency surgery or reintervention
Measured: Procedure
Treatment success
Change of MR grade
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start3 Jun 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Mitral RegurgitationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio Refine Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583876
- Sponsor's protocol ID
- DMS-6470
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
- ClinicalTrials.gov ID
- NCT06583876
- Acronym / sponsor ID
- DMS-6470
- Conditions
- Functional Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bio Refine Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 4 Sep 2024 (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 purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation.
The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive).
Potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.
Additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coriofix treatment | Experimental | Device: Coriofix System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Local heart team has determined that mitral valve surgery will not be offered as a treatment option
- Symptomatic secondary mitral regurgitation (3+ or 4+)
- Adequately treated in compliance with optimal guideline-directed medical therapy for heart failure for at least 90 days
- NYHA functional class II, III or ambulatory IV
- LVEF ≥30%.
Key exclusion criteria (13 listed)
- Untreated clinically significant coronary artery disease requiring revascularization.
- CABG, PCI or TAVR within the prior 90 days.
- Aortic or tricuspid valve disease requiring surgery or transcatheter intervention or severe tricuspid regurgitation.
- COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
- CVA or TIA within prior 180 days.
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 |
|---|---|---|
| Coriofix SystemTreatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus. | Device | Coriofix treatment |
Primary outcome
Coriofix System Safety
Time frame: 30 days
Absence of Major Device- or Procedure-Related Serious Adverse Events
3 secondary outcomes
Coriofix System Safety
Time frame: 6 and 12 months
Device technical success
Time frame: Procedure
Treatment success
Time frame: 30 days
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 2 Oct 2026.
- Individual participant dataSharing planned: No
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PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
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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.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coriofix System in people with Functional Mitral Regurgitation, run by Bio Refine Ltd. at 8 sites in 4 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 6 inclusion and 13 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland, Hungary, Serbia, Israel. 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 Boaz Shenhav (972-52-561-1151, boaz.s@bio-refine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coriofix System Safety (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 2 Oct 2026.