Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility 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).
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Boaz Shenhav
- Phone Number: 972-52-561-1151
- Email: boaz.s@bio-refine.com
Study Locations
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Budapest, Hungary
- Recruiting
- Gottsegen National Cardiovascular Center
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Contact:
- Géza Fontos, MD
- Phone Number: +36 70 3820358
- Email: geza.fontos@gmail.com
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Debrecen, Hungary
- Recruiting
- University of Debrecen
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Contact:
- Attila Kertész, MD
- Phone Number: +36-30-3996248
- Email: kertesz@med.unideb.hu
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Principal Investigator:
- Attila Kertész, MD
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Petah Tikva, Israel
- Recruiting
- Rabin Medical Center
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Contact:
- Leor Perl, MD
- Phone Number: +972-3-937-4666
- Email: leorper@clalit.org.il
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Katowice, Poland
- Recruiting
- Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
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Contact:
- Wojciech Wojakowski, MD
- Phone Number: + 48323598000
- Email: wojtek.wojakowski@gmail.com
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Poznan, Poland
- Recruiting
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Contact:
- Marek Grygier, MD
- Phone Number: + 48618549121
- Email: marek.grygier@usk.poznan.pl
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Warsaw, Poland
- Not yet recruiting
- Wojskowy Instytut Medyczny
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Contact:
- Michał Zembala MD, PhD Michał Zembala MD, PhD, MD
- Phone Number: +48 600 402 994
- Email: m.zembala.jr@icloud.com
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Belgrade, Serbia
- Terminated
- Institute for Cardiovascular Diseases "Dedinje"
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Kragujevac, Serbia
- Withdrawn
- University Clinical Center Kragujevac
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coriofix treatment
|
Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coriofix System Safety
Time Frame: 30 days
|
Absence of Major Device- or Procedure-Related Serious Adverse Events |
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coriofix System Safety
Time Frame: 6 and 12 months
|
Absence of Major Device- or Procedure-Related Serious Adverse Events |
6 and 12 months
|
|
Device technical success
Time Frame: Procedure
|
Successful system operation with no related emergency surgery or reintervention |
Procedure
|
|
Treatment success
Time Frame: 30 days
|
Change of MR grade |
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DMS-6470
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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