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Completed

NCT Number: NCT02506387

Belgian Mitraclip Registry

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.

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Key information

Conditions

Mitral Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital Antwerp, Edegem, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mitraclip

Device

The decision to implant mitraclip is not part of this observational study but is made by the heart-team.

Primary outcomes

  1. residual mitral regurgitation (MR) post mitraclip

    Time frame: at day 3-5 post mitraclip implantation

    MR grade 1 tot 4, as assessed on echocardiography

  2. cardiac mortality

    Time frame: 2 years

  3. surgical mitral valve intervention

    Time frame: 2 years

  4. hospitalization for heart failure

    Time frame: 2 years

    heart failure as primary reason of hospitalization

Secondary outcomes

  1. pericardial effusion

    Time frame: day 1-2 after mitraclip implantation

    peri-procedural pericardial effusion with hemodynamic impact as assessed on echocardiography

  2. change in New York Heart Association (NYHA) classification

    Time frame: 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

  3. distance during 6 min walking test

    Time frame: 1 year

    distance expressed in meters assessed baseline, 6 month and 1 y after mitraclip implantation.

  4. Left ventricular (LV) remodeling

    Time frame: 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

  5. Acute renal failure requiring dialysis

    Time frame: up to one month after mitraclip implantation

    Acute renal failure requiring dialysis

  6. urgent surgical mitral valve intervention

    Time frame: within 24h after procedure

    urgent surgical mitral valve intervention

  7. Change in Left ventricular ejection fraction (LVEF)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2024
First posted
Jul 23, 2015
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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