Belgian Mitraclip Registry
1 other identifier
observational
520
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 19, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 18, 2025
July 1, 2025
8 years
July 19, 2015
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (7)
pericardial effusion
day 1-2 after mitraclip implantation
change in New York Heart Association (NYHA) classification
2 years
distance during 6 min walking test
1 year
Left ventricular (LV) remodeling
6 month
Acute renal failure requiring dialysis
up to one month after mitraclip implantation
- +2 more secondary outcomes
Study Arms (1)
Mitraclip patients
Patients with severe mitral regurgitation in whom decision for mitraclip implantation was made by the heart team.
Interventions
The decision to implant mitraclip is not part of this observational study but is made by the heart-team.
Eligibility Criteria
Patient with symptomatic severe mitral regurgitation at too high risk voor cardiac surgery and with suitable anatomy for mitraclip implantation
You may qualify if:
- severe mitral regurgitation
- symptomatic (NYHA class\>1) despite optimal medical therapy
- suitable anatomy for mitraclip implantation
- too high risk for cardiac surgery
You may not qualify if:
- \<1 year life expectancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University hospital Antwerp
Edegem, Antwerp, 2070, Belgium
OLV Aalst
Aalst, Belgium
Biospecimen
serum sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof dr
Study Record Dates
First Submitted
July 19, 2015
First Posted
July 23, 2015
Study Start
January 1, 2015
Primary Completion
January 1, 2023
Study Completion
December 1, 2024
Last Updated
July 18, 2025
Record last verified: 2025-07