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
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
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- 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