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Tests treatment safety and results for Functional Mitral Regurgitation
Official title Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU
ClinicalTrials.gov ID: NCT06823700
What this study is testing
- What it's testing
- The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant who has provided written informed consent for the investigation.
- Age ≥18 years.
- Patients diagnosed with FMR.
- MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).
- LVEF ≥20% to ≤60%.
You likely can't join if
- Life expectancy \<1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.
- Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.
- UNOS status 1 heart transplantation or prior orthotopic heart transplantation.
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other...
- Fixed pulmonary artery systolic pressure \>70 mm Hg.
- Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
See the full eligibility criteria
Who can join
- Participant who has provided written informed consent for the investigation.
- Age ≥18 years.
- Patients diagnosed with FMR.
- MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).
- LVEF ≥20% to ≤60%.
- Symptom status: NYHA functional class II to IV despite a stable maximally tolerated GDMT regimen as per guidelines.
- According to the judgment of local cardiology team, people have undergone adequate treatment for at least 30 days (preferably 90 days) based on the criteria recommended in the heart failure guidelines.
- Subject fulfils FMR anatomy selection criteria.
- According to the judgment of the local Cardiovascular medical-surgery team, people who have high or prohibitive risk for open heart surgery.
- Left ventricular end-systolic diameter (LVESD)≤70mm.
- The MR beam mainly originates from the A2/P2 area.
- Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\>10mm.
- Mitral valve effective orifice area (EOA) ≥ 4.0cm2.
- No obvious calcification of main grasp mitral valve leaflets.
- Patient anatomy allows atrial septum approach.
What rules you out
- Life expectancy \<1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.
- Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.
- UNOS status 1 heart transplantation or prior orthotopic heart transplantation.
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic...
- Fixed pulmonary artery systolic pressure \>70 mm Hg.
- Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
- Mitral valve anatomy which may preclude proper device treatment.
- Mitral valve area \< 4.0 cm2 (if new device therapy may further decrease the mitral orifice area).
- Any prior mitral valve surgery or transcatheter mitral valve procedure.
- Stroke or transient ischemic event within 30 days before enrolment.
- Modified Rankin ≥ Scale 4 disability.
- Severe symptomatic carotid stenosis (\>70% by ultrasound).
- Need for emergent or urgent intervention for any reason or any planned cardiac intervention within the next 12 months.
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 1 month before enrolment.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Any percutaneous cardiovascular intervention, cardiovascular intervention, or carotid intervention within 30 days
- Tricuspid valve disease requiring intervention or severe or more tricuspid regurgitation.
- Aortic valve disease requiring intervention or any concomitant treatment.
- Need for any cardiovascular intervention (other than for MV disease).
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Active endocarditis.
- Active infections requiring current antibiotic therapy.
- people in whom transoesophageal echocardiography is contraindicated or high risk.
- Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.
- Patient unable or unwilling to provide written, informed consent before study enrolment.
- Pregnant woman or woman planning to become pregnant.
- Patients with severe liver, renal or pulmonary disease, which in investigator opinion may have an impact on patient safety.
- Clinically significant lab abnormalities which in investigator opinion may have an impact on patient safety.
The study team makes the final eligibility decision.
Where it's taking place
- Valladolid, Valladolid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valladolid, Valladolid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.