significant atrial functional mitral regurgitation (aFMR) and Heart failure with preserved ejection fraction (HFpEF) I50.12 I50.13 I50.14 I50.19 I34.0
Conditions
Interventions
Group 1: Mitral Valve Transcatheter Edge-to-edge Repair (TEER) + Guideline directed
medical therapy (GDMT) for heart failure
Group 2: Guideline directed medical therapy (GDMT)
Sponsors
Universitätsklinikum Bonn AöR
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria: 1. Male or female participants, age = 60 years and = 90 years o Female participants of nonchildbearing potential are defined as: Postmenopausal state (reports history of amenorrhea for = 24 con-secutive months prior to screening without an alternative medical cause) or surgically sterilized/ hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases 2. Written informed consent for study participation available 3. Patient is able to follow study instructions (including six-minute-walk test) and to comply with necessary study visits. Agreement for com-pleting follow-up visits at the center is given. Indication-specific inclusion criteria: 4. Significant aFMR (> grade II, according to current ESC-guidelines, con-firmed by Echocardiography Core Laboratory, Examination = 90 days before Inclusion and under stable GDMT for four weeks, except diuret-ics) with high surgical risk (by heart team decision) o Left ventricular end-diastolic volume index 35 mm o Left atrial volume index > 34 ml/m2 o Normal leaflet motion and morphology 5. Left ventricular ejection fraction = 50 % under GDMT 6. Mitral valve area > 4 cm2 (assessed by CoreLab) 7. Heart failure symptoms = NYHA II while receiving optimal GDMT 8. At least one hospitalization for heart failure within the last 12 months, or NTproBNP level > 300 pg/ml in patients with non-AF rhythm, respec-tively 900 pg/ml in patients with atrial fibrillation
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. Participants without legal capacity who is unable to understand the na-ture, scope, significance and consequences of this study. 2. Physical or psychiatric condition which at the physician’s discretion may put the study participant at risk, may confound the study results, or may interfere with the participant’s participation in this study. 3. Simultaneous participation in another clinical study, or participation in a clinical trial taking an investigational product, up to 30 days prior to last I(M)P intake/ to participation in that clinical study. 4. Prior or persistent abuse of medication, drugs or alcohol/ reported history (within the last 12 months before screening) or persistent abuse of med-ication, abuse of drugs or alcohol misuse as assessed by the investigator considering participant’s safety and adherence to treatment 5. Untreatable allergy/ incompatibility to procedural anticoagulation or im-plant components (nickel-titanium alloy, cobalt-chromium alloy Indication specific exclusion criteria: 6. Mitral valve surgery as preferred therapy option (heart team) 7. Mitral regurgitation is categorized as primary/ degenerative valvulopathy 8. Presence of concomitant mitral stenosis, defined as mean pressure gra-dient > 3,5 mmHg 9. Mitral valve/ annulus anatomy not feasible for TEER (e.g. large coapta-tion defect, severe calcification of mitral leaflets/ annulus) 10. Anatomical situation is preventing TEER because of venous access (e.g. deep vein thrombosis, vena cava filter), transseptal puncture (e.g. throm-bus, interatrial implanted device) or contraindication for transesophageal echocardiography (e.g. esophageal varices, ulcerating malignoma). 11. Patient in need for urgent TEER 12. Planned or prior heart transplantation/ LVAD therapy 13. Prior mitral valve implantation/ reconstruction in surgical or interventional manner 14. Chronic kidney disease requiring renal replacement therapy 15. Chronic obstructive pulmonary disease GOLD III or IV 16. Constrictive pericarditis 17. Primary cardiomyopathy (e.g. amyloidosis, sarcoidosis, restrictive cardi-omyopathy, hemochromatosis) 18. Life expectancy < 12 months 19. Current situation of blood stream infection or endocarditis requiring anti-biotic therapy 20. Severe aortic stenosis or regurgitation 21. Severe right ventricular dysfunction (defined as RV-FAC < 20% or = 2 of the following: TAPSE < 14 mm, TDI S’ < 9 cm/s, or RV-FAC < 25%) 22. TR grade = severe, according to RT Hahn et al.1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint of cardiovascular mortality, heart failure hospitalization/ worsening* (for detail definition of * see section 6) of heart failure, improvement of < 10 points in KCCQ at month 12 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Device safety, MR severity, Clinical parameters, Hemodynamic effects, ventricular and atrial function, Functional capability, Laboratory | — |
Countries
Germany
Contacts
Public ContactCan Öztürk
Universitätsklinikum Bonn AöR
Outcome results
None listed