I34.0
Conditions
Interventions
Group 1: M-TEER only: Patients randomized to M-TEER only will not undergo PVI prior to M-TEER. The baseline right heart catheterization (RHC) will act as a PVI sham procedure to blind the patient. The
Sponsors
Herzzentrum Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients with severe functional mitral regurgitation and an indication for transcatheter edge-to-edge mitral valve repair judged by the local heart team Patients with documented paroxysmal or persistent atrial fibrillation with no previous ablation of atrial fibrillation NYHA functional class II, III or ambulatory IV The primary regurgitant jet, in the opinion of the MitraClip/ PASCAL implanting investigator, can be successfully treated by the MitraClip/PASCAL device Patients willing to provide written informed consent and comply with protocol-specified follow-up evaluations
Exclusion criteria
Exclusion criteria: Previous mitral valve surgery or intervention Contraindications to M-TEER or PVI Leaflet anatomy which may preclude M-TEER-device deployment Patients with permanent atrial fibrillation Patients with one or more prior ablations of atrial fibrillation LAA thrombus or insufficient oral anticoagulation within the last 3 weeks Echocardiographic evidence of intracardiac mass, thrombus or vegetation NYHA functional class IV requiring in-hospital care Active infections requiring current antibiotic therapy Life expectancy less than 12 months due to non-cardiovascular reasons Pregnancy or lactation Hemodynamic instability requiring inotropic support or mechanical heart assistance Prior mitral valve leaflet surgery or intervention Participation in another clinical trial with an investigational device or drug that could interfere with the outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cardiac power index from baseline to follow-up right heart catheterization | — |
Secondary
| Measure | Time frame |
|---|---|
| Atrial fibrillation burden Composite endpoint of heart failure hospitalization and mortality Heart failure hospitalization All-cause mortality Change in quality of life (KCCQ) AF symptom burden (AFEQT) Distribution of NYHA functional class Change in NTproBNP level Change in LVESV, LVEDV, LVEF, LAVI, LA fibrosis (MRI) M-TEER and PVI- related complications | — |
Countries
Germany
Contacts
Public ContactTobias Kister
Herzzentrum Leipzig
Outcome results
None listed