Mitral Valve InsufficiencyNCT02506387
Belgian Mitraclip Registry
An observational study of Mitral Valve Insufficiency, run by Universiteit Antwerpen at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- mitraclip
- Type of treatment
- Medical device
- How many people
- 520 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2015to Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with symptomatic severe mitral regurgitation at too high risk voor cardiac surgery and with suitable anatomy for mitraclip implantation
Who may be able to join
- severe mitral regurgitation
- symptomatic (NYHA class>1) despite optimal medical therapy
- suitable anatomy for mitraclip implantation
- too high risk for cardiac surgery
Who cannot join
- <1 year life expectancy
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
OLV Aalst
Aalst
University hospital Antwerp
Edegem, Antwerp, 2070
About this study
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
- Mitral Valve Insufficiency
- Being tested
- mitraclip
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitraclipDevice
The decision to implant mitraclip is not part of this observational study but is made by the heart-team.
| Study group | Role | What they receive |
|---|---|---|
| Mitraclip patients | Patients with severe mitral regurgitation in whom decision for mitraclip implantation was made by the heart team. Receives: Device: mitraclip |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual mitral regurgitation (MR) post mitraclip
MR grade 1 tot 4, as assessed on echocardiography
Measured: at day 3-5 post mitraclip implantation
cardiac mortality
Measured: 2 years
surgical mitral valve intervention
Measured: 2 years
hospitalization for heart failure
heart failure as primary reason of hospitalization
Measured: 2 years
Secondary outcomes (7)
pericardial effusion
peri-procedural pericardial effusion with hemodynamic impact as assessed on echocardiography
Measured: 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
Measured: 2 years
distance during 6 min walking test
distance expressed in meters assessed baseline, 6 month and 1 y after mitraclip implantation.
Measured: 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
Measured: 6 month
Acute renal failure requiring dialysis
Acute renal failure requiring dialysis
Measured: up to one month after mitraclip implantation
urgent surgical mitral valve intervention
urgent surgical mitral valve intervention
Measured: 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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2023
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M Claeys, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506387
- Sponsor's protocol ID
- BEL 0
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2015
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Mitraclip Registry
- ClinicalTrials.gov ID
- NCT02506387
- Acronym / sponsor ID
- BEL 0
- Conditions
- Mitral Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2023 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitraclip patients | – | Device: mitraclipPatients with severe mitral regurgitation in whom decision for mitraclip implantation was made by the heart team. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with symptomatic severe mitral regurgitation at too high risk voor cardiac surgery and with suitable anatomy for mitraclip implantation
Key inclusion criteria (4 listed)
- severe mitral regurgitation
- symptomatic (NYHA class>1) despite optimal medical therapy
- suitable anatomy for mitraclip implantation
- too high risk for cardiac surgery
Key exclusion criteria (1 listed)
- <1 year life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mitraclipThe decision to implant mitraclip is not part of this observational study but is made by the heart-team. | Device | Mitraclip patients |
Primary outcome
residual mitral regurgitation (MR) post mitraclip
Time frame: at day 3-5 post mitraclip implantation
MR grade 1 tot 4, as assessed on echocardiography
cardiac mortality
Time frame: 2 years
surgical mitral valve intervention
Time frame: 2 years
hospitalization for heart failure
Time frame: 2 years
heart failure as primary reason of hospitalization
7 secondary outcomes
pericardial effusion
Time frame: day 1-2 after mitraclip implantation
change in New York Heart Association (NYHA) classification
Time frame: 2 years
distance during 6 min walking test
Time frame: 1 year
Left ventricular (LV) remodeling
Time frame: 6 month
Acute renal failure requiring dialysis
Time frame: up to one month after mitraclip implantation
urgent surgical mitral valve intervention
Time frame: within 24h after procedure
Change in Left ventricular ejection fraction (LVEF)
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
Related trials for Mitral Valve Insufficiency
Recruiting
MRS Measurement of Glutamate and GABA Metabolism in Brain
Normal Physiology
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Insufficiency, run by Universiteit Antwerpen at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual mitral regurgitation (MR) post mitraclip (time frame: at day 3-5 post mitraclip implantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.