Mitral Valve Insufficiency
Conditions
Brief summary
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.
Interventions
DEVICEmitraclip
The decision to implant mitraclip is not part of this observational study but is made by the heart-team.
Sponsors
Universiteit Antwerpen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| residual mitral regurgitation (MR) post mitraclip | at day 3-5 post mitraclip implantation | MR grade 1 tot 4, as assessed on echocardiography |
| cardiac mortality | 2 years | — |
| surgical mitral valve intervention | 2 years | — |
| hospitalization for heart failure | 2 years | heart failure as primary reason of hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute renal failure requiring dialysis | up to one month after mitraclip implantation | Acute renal failure requiring dialysis |
| pericardial effusion | day 1-2 after mitraclip implantation | peri-procedural pericardial effusion with hemodynamic impact as assessed on echocardiography |
| Change in Left ventricular ejection fraction (LVEF) | 6 month | 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 |
| urgent surgical mitral valve intervention | within 24h after procedure | urgent surgical mitral valve intervention |
| change in New York Heart Association (NYHA) classification | 2 years | NYHA 1-4 as assessed by the clinician at baseline and 1 month, 6 month, 1 year and 2 year after mitraclip implantation |
| distance during 6 min walking test | 1 year | distance expressed in meters assessed baseline, 6 month and 1 y after mitraclip implantation. |
| Left ventricular (LV) remodeling | 6 month | 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 |
Countries
Belgium
Outcome results
None listed