Belgian Mitraclip Registry | NCT02506387

Studies
Belgian Mitraclip Registry

NCT02506387

Sponsor

Universiteit Antwerpen

Status

Completed

Last Update Posted

Jul 18, 2025Actual

Enrollment

520Actual

Phase

Not provided

Conditions

Mitral Valve Insufficiency

Interventions

mitraclip

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2023Actual

Completion Date

Dec 2024Actual

First Submitted Date

Jul 19, 2015

First Submission Date that Met QC Criteria

Jul 21, 2015

First Posted Date

Jul 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2025

Last Update Posted Date

Jul 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

520Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitraclip patients		Patients with severe mitral regurgitation in whom decision for mitraclip implantation was made by the heart team.	Device: mitraclip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mitraclip	Device	The decision to implant mitraclip is not part of this observational study but is made by the heart-team.	Mitraclip patients

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Antwerp		Edegem	Antwerp	2070	Belgium
OLV Aalst

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided