An interventional study of Guideline-Directed Medical Therapy (GDMT) and Mitral valve TEER in Heart Failure - NYHA II - IV and Mitral Regurgitation Functional, sponsored by Jena University Hospital. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Jena University Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether mitral valve transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy (GDMT) can improve clinical outcomes and symptoms in heart failure patients with non-severe secondary mitral regurgitation (SMR) at rest and exercise-induced severe SMR.
The main questions it aims to answer are:
Participants will:
The patients' echocardiographic data will undergo an additional centralized assessment by an independent Core Laboratory.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 246 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Jena University Hospital is the lead sponsor of 64 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exacerbation of SMR to exercise-induced severe (3+/4+) SMR defined by at least one of the following:
Increase in natriuretic peptides defined as NT-proBNP:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive GDMT according to current heart failure and valvular heart disease guidelines.
Other: Guideline-Directed Medical Therapy (GDMT)
Participants receive GDMT plus mitral valve TEER
Procedure: Mitral valve TEER
Participants receive guideline-directed medical therapy (GDMT) for heart failure and secondary mitral regurgitation (SMR) according to current clinical practice guidelines. Medical treatment may include optimized pharmacological therapy such as beta-blockers, ACE inhibitors/ARBs/ARNI, mineralocorticoid receptor antagonists, diuretics, SGLT2-inhibitors and other indicated medications. Treatment is adjusted based on clinical status and treating physician judgment.
Participants receive guideline-directed medical therapy (GDMT) for heart failure and secondary mitral regurgitation (SMR) according to current clinical practice guidelines in combination with TEER of the mitral valve using the PASCAL Precision system (Edwards Lifesciences Sàrl). The procedure is performed via a minimally invasive transcatheter approach through femoral venous access to reduce SMR. Guideline-directed medical therapy is continued and optimized throughout follow-up according to standard of care.
Four-step hierarchical composite primary endpoint; win ratio based on the following parameters: time to all-cause mortality at 12 months, time to first HF hospitalization, SMR progression (3+/4+) at rest, change in KCCQ score from baseline to 12 months.
The primary outcome is a single aggregated, unitless win ratio based on a four-step hierarchical composite primary endpoint at 12 months. Each patient in the GDMT+mitral valve TEER group will be compared with each patient in the GDMT group with respect to the following parameters in the following order: 1. time to all-cause mortality, days 2. time to first heart failure hospitalization, days 3. secondary mitral regurgitation progression (3+/4+) at rest and 4. change in KCCQ score from baseline to 12 months, where higher improvement or less deterioration wins; differences between patients less than 5 points are treated as ties (i.e. a between-patient threshold of 5 pts., KCCQ-values range from 0 to 100, higher values indicating better health). For each pairwise comparison, the first non-tied component determines a win for one group or a tie. The win ratio is the number of wins in the GDMT+ mitral valve TEER group divided by the number of wins in the GDMT group.
Time frame: 12 months
Number of participants with cardiovascular death
Death due to cardiovascular causes during follow-up.
Time frame: 12 months
Number of participants with heart failure hospitalization
Hospitalization due to worsening heart failure requiring inpatient treatment.
Time frame: 12 months
Number of participants with myocardial infarction
Occurrence of myocardial infarction during follow-up.
Time frame: 12 months
Number of participants with stroke
Occurrence of ischemic or hemorrhagic stroke during follow-up.
Time frame: 12 months
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ): scores range from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline, 1, 6, and 12 months
Change from baseline in 36-Item Short Form Survey (SF-36) score
General health-related quality of life assessed using the SF-36 questionnaire, including physical and mental component summary scores.
Time frame: Baseline, 1, 6, and 12 months
Number of participants requiring mitral valve surgery
Occurrence of surgical mitral valve intervention during follow-up.
Time frame: 12 months
Change from baseline in secondary mitral regurgitation severity grade according to the American Society of Echocardiography (ASE) criteria at rest
Secondary mitral regurgitation severity will be assessed at rest by transthoracic echocardiography according to the American Society of Echocardiography (ASE) criteria using a 4-grade scale: Grade 1 (mild), Grade 2 (moderate), Grade 3 (moderate-to-severe), and Grade 4 (severe). Severity grading will be based on an integrated assessment of echocardiographic parameters, including effective regurgitant orifice area (EROA), regurgitant volume (RVol), and regurgitant fraction (RF).
Time frame: Baseline, 1, 6, and 12 months
Change from baseline in left ventricular end-systolic volume index (LVESVi)
Left ventricular end-systolic volume index measured by echocardiography.
Time frame: Baseline, 1, 6, and 12 months
Change from baseline in left ventricular end-diastolic volume index (LVEDVi)
Left ventricular end-diastolic volume index measured by echocardiography.
Time frame: Baseline, 1, 6, and 12 months
Change from baseline in pulmonary artery systolic pressure (SPAP)
Pulmonary artery systolic pressure assessed by echocardiography.
Time frame: Baseline, 1, 6, and 12 months
Change from baseline in New York Heart Association (NYHA) functional class
Heart failure functional status assessed using NYHA classification.
Time frame: Baseline, 1, 6, and 12 months
Change from baseline in six-minute walk test (6MWT) distance
Exercise capacity assessed using the six-minute walk test.
Time frame: Baseline, 1, 6, and 12 months
Change from baseline in NT-proBNP (N-terminal pro Brain natriuretic peptide, pg/ml) (alternatively calculated from BNP, Brain natriuretic peptide, pg/ml)
Heart failure biomarkers measured in blood samples.
Time frame: Baseline, 1, 6, and 12 months
Number of participants with all-cause mortality
Death from any cause during the study follow-up period.
Time frame: 12 months
Number of participants with procedure-related complications during TEER
Complications occurring during or immediately after the TEER procedure.
Time frame: During procedure
Number of participants requiring non-elective cardiovascular surgery for device-related complications
Emergency or unplanned cardiovascular surgery related to the device or procedure.
Time frame: 12 months
Number of participants with endocarditis
Occurrence of infective endocarditis during follow-up.
Time frame: 12 months
Number of participants with major bleeding (TIMI criteria)
Major bleeding events defined according to the Thrombolysis In Myocardial Infarction (TIMI) bleeding criteria, including fatal bleeding, intracranial hemorrhage, or clinically significant bleeding associated with a drop in hemoglobin ≥5 g/dL or hematocrit ≥15%.
Time frame: 12 months
Number of participants with cardiac tamponade
Occurrence of pericardial tamponade.
Time frame: 12 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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