Belgian Mitraclip Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Mitraclip patients Patients with severe mitral regurgitation in whom decision for mitraclip implantation was made by the heart team. |
Device: mitraclip
The decision to implant mitraclip is not part of this observational study but is made by the heart-team.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- pericardial effusion [day 1-2 after mitraclip implantation]
peri-procedural pericardial effusion with hemodynamic impact as assessed on echocardiography
- 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
- Acute renal failure requiring dialysis [up to one month after mitraclip implantation]
Acute renal failure requiring dialysis
- urgent surgical mitral valve intervention [within 24h after procedure]
urgent surgical mitral valve intervention
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospital Antwerp | Edegem | Antwerp | Belgium | 2070 |
| 2 | OLV Aalst | Aalst | Belgium |
Sponsors and Collaborators
- Universiteit Antwerpen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BEL 0