Belgian Mitraclip Registry

Mitral Valve Insufficiency Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02506387
• Other study ID #: BEL 0
• Status: Recruiting
• Start date: January 2015
• Est. completion date: December 2025

Study information

• Verified date: November 2022
• Source: Universiteit Antwerpen
• Contact: Marc Claeys, MD, PhD
• Phone: 003238214706
• Email: marc.claeys[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	residual mitral regurgitation (MR) post mitraclip	MR grade 1 tot 4, as assessed on echocardiography	at day 3-5 post mitraclip implantation
Primary	cardiac mortality		2 years
Primary	surgical mitral valve intervention		2 years
Primary	hospitalization for heart failure	heart failure as primary reason of hospitalization	2 years
Secondary	pericardial effusion	peri-procedural pericardial effusion with hemodynamic impact as assessed on echocardiography	day 1-2 after mitraclip implantation
Secondary	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
Secondary	distance during 6 min walking test	distance expressed in meters assessed baseline, 6 month and 1 y after mitraclip implantation.	1 year
Secondary	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
Secondary	Acute renal failure requiring dialysis	Acute renal failure requiring dialysis	up to one month after mitraclip implantation
Secondary	urgent surgical mitral valve intervention	urgent surgical mitral valve intervention	within 24h after procedure
Secondary	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