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New treatment option for Heart Failure
Official title Mitral Regurgitation Treatment in Advanced Heart Failure
ClinicalTrials.gov ID: NCT05292716
What this study is testing
- What it's testing
- MITRADVANCE-HF is a prospective, randomized, parallel-controlled, open-label, multicentre study trial enrolling patients with SMR and advanced HF on maximally tolerated standard of care therapies for HF according to the most recent guidelines. Enrolled patients will be randomly assigned, in a 1:1 ratio, to a device arm consisting of MitraClip therapy added to optimal medical therapy (OMT) or a control arm of OMT alone.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Age between 18 and 90 years
- Significant secondary mitral regurgitation (effective regurgitant orifice area ≥ 5 30mm2) confirmed at the end of the screening period
- Optimal medical therapy (OMT) according to recent guidelines.
- Advanced heart failure defined as the presence of all the following criteria, despite OMT:
- Severe and persistent symptoms of HF (NYHA class III or IV)
You likely can't join if
- Unfavorable mitral valve anatomy, which implanting investigator judges as not successfully treatable by the MitraClip (i.e. mitral valve area \<3...
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
- Active infections requiring current antibiotic therapy
- Transesophageal echocardiography (TEE) contraindicated or at high risk
- Untreated significant coronary artery disease requiring revascularization
See the full eligibility criteria
- Age between 18 and 90 years
- Significant secondary mitral regurgitation (effective regurgitant orifice area ≥ 5 30mm2) confirmed at the end of the screening period
- Optimal medical therapy (OMT) according to recent guidelines.
- Advanced heart failure defined as the presence of all the following criteria, despite OMT:
- Severe and persistent symptoms of HF (NYHA class III or IV)
- Severe cardiac dysfunction defined by a reduced left ventricular ejection fraction (LVEF) ≤35% and/or high BNP or NTproBNP levels (BNP\>125 pg/ml or NTproBNP\>400 pg/ml if sinus rhythm; BNP\>375 pg/ml or NTproBNP\>1200...
- Impairment of quality of life (KCCQ \< 75 points) AND severe impairment of exercise capacity with inability to exercise or low 6MWT distance (\<450 meters) or pVO2 (\<14 mL/kg/min or \<50% of predicted) OR at least 1...
- Unfavorable mitral valve anatomy, which implanting investigator judges as not successfully treatable by the MitraClip (i.e. mitral valve area \<3 mm2, leaflet length \<7 mm)
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
- Active infections requiring current antibiotic therapy
- Transesophageal echocardiography (TEE) contraindicated or at high risk
- Untreated significant coronary artery disease requiring revascularization
- Iron deficiency defined as serum ferritin \<100 μg/L, or ferritin between 100-299 μg/L and transferrin saturation \<20% and/or intravenous ferric carboxymaltose administration during the 30 days before randomization
- Coronary artery bypass graft, percutaneous coronary intervention, transcatheter aortic valve replacement or cardiac resynchronization therapy within the prior 30 days
- Pulmonary vein ablation or cardioversion leading to restore of sinus rhythm or AV node ablation in the last 30 days
- Myocardial infarction or cerebrovascular accident within prior 30 days
- Hemodynamic instability defined as systolic blood pressure \< 90mmHg and cardiogenic shock or need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
- Chronic obstructive pulmonary disease, malignancy, or other comorbidities as the main cause of severe symptoms and impaired quality of life.
- Life expectancy \<12 months due to non-cardiac conditions
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, Lombardy, Italy
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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, Lombardy, Italy. 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.