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Device
Transcatheter Edge-to-Edge Repair for Mitral Valve Regurgitation (MINOS Trial)
N/A
Recruiting
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
SCAI stage C or D cardiogenic shock with persistent inotrope/vasopressor/non-durable mechanical support or unable to wean ventilatory support due to pulmonary edema for 24 hours prior to randomization
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
MINOS Trial Summary
This trial will help to determine if transcatheter edge-to-edge repair improves outcomes for patients with cardiogenic shock and mitral regurgitation.
Who is the study for?
This trial is for adults over 18 with cardiogenic shock and severe mitral valve regurgitation who are dependent on heart support drugs or ventilators. They must be able to give consent and have a heart structure suitable for the TEER procedure. Excluded are those recently revascularized, with active infections in the heart, certain neurological or pregnancy conditions, hypersensitivity to procedure meds, severe aortic disease, plans for other heart supports, prior mitral surgery except ring placement, or life-limiting comorbidities.Check my eligibility
What is being tested?
The study compares two treatments: standard medical therapy versus Transcatheter edge-to-edge repair (TEER) in patients with advanced cardiogenic shock and significant mitral regurgitation. It's an open-label randomized-controlled trial aiming to see if TEER can improve outcomes better than just medication.See study design
What are the potential side effects?
While specific side effects aren't listed here, procedures like TEER could potentially cause complications such as bleeding at the catheter site, infection risk from invasive procedures, damage to the heart or vessels during operation and possible need for more surgeries if complications occur.
MINOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe heart failure needing constant medication or mechanical support.
Select...
I am 18 years old or older.
MINOS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary composite outcome
Secondary outcome measures
Bleeding
Cardiac structural complications
Device success
+7 moreOther outcome measures
All-cause hospitalization
All-cause mortality
Any re-intervention on the mitral valve
MINOS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transcatheter edge-to-edge repairExperimental Treatment1 Intervention
The experimental arm includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support plus transcatheter edge-to-edge repair
Group II: Medical therapyActive Control1 Intervention
Medical therapy includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support.
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,292 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart failure needing constant medication or mechanical support.My heart valve issue is due to wear and tear, and I am considered for surgery.I am 18 years old or older.I am scheduled for a heart pump implant before my valve repair.I experienced a cardiac arrest without recovering neurologically.My heart team believes I am a good candidate for a specific valve repair to improve my heart function.I had a procedure to improve blood flow to my heart within the last 2 days.I have been diagnosed with an active heart infection.You cannot have a transesophageal echocardiogram.I have severe aortic valve disease.I have had surgery on my mitral valve or have a mitral valve implant.You have severe mitral regurgitation, as determined by a special heart test called a transesophageal echocardiogram (TEE).My heart scan shows a mass or clot on the left side.The shape of your mitral valve makes it unsuitable for the TMVr implant, and it can't be fixed with a procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Medical therapy
- Group 2: Transcatheter edge-to-edge repair
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals able to volunteer for this research effort at the present time?
"According to clinicaltrials.gov, this research trial is currently in the patient recruitment stage with an initial posting on May 26th 2022 and a recent update on October 7th of that same year."
Answered by AI
How many candidates are eligible for this clinical research?
"Affirmative. Clinicaltrials.gov states that this medical evaluation is accepting applicants, with the initial posting of May 26th 2022 and most recent adjustment on October 7th 2022. The trial seeks to enrol 144 individuals from one site."
Answered by AI
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