The primary objective of the registry is to investigate and follow all patients treated with the MitraClip System in Belgium. This information is intended to contribute to decision making with regards to MitraClip therapy selection in patients with mitral regurgitation: (a) by establishing the clinical value of the MitraClip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers/government in making coverage decisions. In addition national data will be shared with European registries in order to increase the knowledge about the efficacy of this new technique.
Study Type
OBSERVATIONAL
Enrollment
520
The decision to implant mitraclip is not part of this observational study but is made by the heart-team.
University hospital Antwerp
Edegem, Antwerp, Belgium
OLV Aalst
Aalst, Belgium
residual mitral regurgitation (MR) post mitraclip
MR grade 1 tot 4, as assessed on echocardiography
Time frame: at day 3-5 post mitraclip implantation
cardiac mortality
Time frame: 2 years
surgical mitral valve intervention
Time frame: 2 years
hospitalization for heart failure
heart failure as primary reason of hospitalization
Time frame: 2 years
pericardial effusion
peri-procedural pericardial effusion with hemodynamic impact as assessed on echocardiography
Time frame: day 1-2 after mitraclip implantation
change in New York Heart Association (NYHA) classification
NYHA 1-4 as assessed by the clinician at baseline and 1 month, 6 month, 1 year and 2 year after mitraclip implantation
Time frame: 2 years
distance during 6 min walking test
distance expressed in meters assessed baseline, 6 month and 1 y after mitraclip implantation.
Time frame: 1 year
Left ventricular (LV) remodeling
echocardiac evaluation of LV end diastolic volume (LVEDV) with calculation of LV remodeling according to following formula: (LVEDV at six month - LVEDV baseline)/ LVEDV baseline
Time frame: 6 month
Acute renal failure requiring dialysis
Acute renal failure requiring dialysis
Time frame: up to one month after mitraclip implantation
urgent surgical mitral valve intervention
urgent surgical mitral valve intervention
Time frame: within 24h after procedure
Change in Left ventricular ejection fraction (LVEF)
echocardiac evaluation of LV end systolic volume ( LVESV) and LV end diastolic volume (LVEDV) with calculation of LVEF according to following formula: (LVEDV - LVESV)/ LVEDV . LVEF measured at baseline and 6 month after mitraclip implantation
Time frame: 6 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.