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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Insufficiency
• Intervention / Treatment: Device: mitraclip

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Marc Claeys, MD, PhD; Phone Number: 003238214706; Email: marc.claeys@uantwerpen.be
• Study Contact Backup: Name: Johan Bosmans, MD, PhD; Phone Number: 00328213000; Email: johan.bosmans@uantwerpen.be

Study Locations

• Belgium
  • Aalst, Belgium
    • Recruiting
    • OLV Aalst
    • Contact: Marc Vanderheyden, MD, PhD; Phone Number: 0032 53 72 41 11; Email: marc.vanderheyden@olvz-aalst.be
  • Antwerp
    • Edegem, Antwerp, Belgium, 2070
      • Recruiting
      • University Hospital Antwerp
      • Contact: Marc Claeys, MD PHD; Phone Number: 003238214706; Email: marc.claeys@uantwerpen.be
      • Contact: Bernard Paelinck, MD PHD; Phone Number: 003238213000; Email: bernard.paelinck@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with symptomatic severe mitral regurgitation at too high risk voor cardiac surgery and with suitable anatomy for mitraclip implantation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pericardial effusion	peri-procedural pericardial effusion with hemodynamic impact as assessed on echocardiography	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	2 years
distance during 6 min walking test	distance expressed in meters assessed baseline, 6 month and 1 y after mitraclip implantation.	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	6 month
Acute renal failure requiring dialysis	Acute renal failure requiring dialysis	up to one month after mitraclip implantation
urgent surgical mitral valve intervention	urgent surgical mitral valve intervention	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	6 month

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2025
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: July 19, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (ESTIMATE): July 23, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: BEL 0