Belgian Mitraclip Registry

Recruiting

• Conditions: Mitral Valve Insufficiency
• Interventions: Device: mitraclip

• Registration Number: NCT02506387
• Lead Sponsor: Universiteit Antwerpen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-07-19
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-23
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mitraclip patients	mitraclip	Patients with severe mitral regurgitation in whom decision for mitraclip implantation was made by the heart team.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

University hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium

OLV Aalst; 🇧🇪 Aalst, Belgium