Belgian Mitraclip Registry

Study Overview
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Brief Summary
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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.

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Device: mitraclip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe mitral regurgitation symptomatic (NYHA class>1) despite optimal medical therapy suitable anatomy for mitraclip implantation too high risk for cardiac surgery Exclusion Criteria: <1 year life expectancy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mitraclip patients<br>Patients with severe mitral regurgitation in whom decision for mitraclip implantation was made by the heart team. | Device: mitraclip<br>* The decision to implant mitraclip is not part of this observational study but is made by the heart-team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual mitral regurgitation (MR) post mitraclip | MR grade 1 tot 4, as assessed on echocardiography | at day 3-5 post mitraclip implantation | 
| cardiac mortality |  | 2 years | 
| surgical mitral valve intervention |  | 2 years | 
| hospitalization for heart failure | heart failure as primary reason of hospitalization | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pericardial effusion | peri-procedural pericardial effusion with hemodynamic impact as assessed on echocardiography | 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 | 2 years | 
| distance during 6 min walking test | distance expressed in meters assessed baseline, 6 month and 1 y after mitraclip implantation. | 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 | 6 month | 
| Acute renal failure requiring dialysis | Acute renal failure requiring dialysis | up to one month after mitraclip implantation | 
| urgent surgical mitral valve intervention | urgent surgical mitral valve intervention | 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 | 6 month |