Long Duration Holter ECG in Fabry Disease | NCT04440254

Studies
Long Duration Holter ECG in Fabry Disease

NCT04440254

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Status

Recruiting

Last Update Posted

Feb 18, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Fabry Disease

Interventions

Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device

Countries

France

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

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2021Actual

Primary Completion Date

Apr 30, 2029Estimated

Completion Date

Apr 30, 2029Estimated

First Submitted Date

Jun 12, 2020

First Submission Date that Met QC Criteria

Jun 18, 2020

First Posted Date

Jun 19, 2020Actual

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

Feb 13, 2026

Last Update Posted Date

Feb 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective is to assess the occurrence of cardiac arrhythmias and conduction disorders during a three-year follow-up using implantable Holter ECG monitoring in 40 patients with Fabry disease. The secondary objectives are to analyze the correlations of these anomalies with changes in cardiac MRI and echocardiographic parameters as biological parameters and overall severity of the disease assessed by MSSI.

Detailed Description

The main objective of this non-blinded, monocentric non-randomized study is to assess the occurrence of cardiac arrhythmias and conduction disorders (sinus dysfunction, branch block [BB], atrioventricular block [BAV], sustained [TVS] or non-supported [TVNS] ventricular tachycardias, atrial fibrillation [AF] during a three-year follow-up in 40 patients with Fabry disease (half with left ventricular hypertrophy) using an implantable Holter ECG device (Medtronic Reveal-LINQ™). The secondary objectives are to analyze the correlations (at 1, 2 and 3 years) of these anomalies with the modifications of :

cardiac MRI [Magnetic Resonance Imaging] data at inclusion [M0] and at 36 months [M36] (left ventricular hypertrophy [HVG], amplitude of the T1 signal, extent of fibrosis); MRIs will be performed before implantation and after removal of the Holter to avoid the reading artifacts linked to the device.
echocardiographic measurements of the left ventricle (overall longitudinal strain systolic [SGL] and ejection fraction [FE])
biological parameters (BNP or NT-proBNP, ultra-sensitive troponin and Lyso-Gb3)
the overall severity of the disease assessed by MSSI (Mainz Severity Score Index), DFG and proteinuria

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ONE	Other	One single group of patients	Diagnostic Test: Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device	Diagnostic Test	Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of cardiac arrhythmias and conduction disorders		3 years

Secondary Outcomes

Measure	Description	Time Frame
Correlations between electrical disorders and changes in MRI/ultrasonic data (LV mass, T1 signal, fibrosis extent , systolic strain, ejection fraction), concentrations of BNP, troponin, Lyso-Gb3, MSSI score and renal function		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patient
Age greater than or equal to 18 years on the day of inclusion
Presence of a morbid mutation for MF
Signature of the informed consent form
Absence of significant valve disease, verified on medical file (absence stenosis or regurgitation <2+ in color Doppler on a scale 1 to 4+ by extension of the jet)
No history of known or documented myocardial infarction nor CAD
No pacemaker or ICD
no history of AF, NSVT, high-degree AV block
Correct echogenicity
No treatment by corticosteroid or immunosuppressive drugs
creatinine clearance >/= 30 Ml/mn
LVEF ≥ 50% by ultrasound and / or MRI
No contraindication to MRI (or claustrophobia) and gadolinium injection
Affiliation to the French social security insurance

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Albert HAGEGE, Dr	Contact	0156093713		albert.hagege@inserm.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
20 Rue Leblanc, HEGP/PARCC, 75015 Paris	Recruiting	Paris	Paris	75015	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000795	Fabry Disease

Ancestor Terms

ID	Term
D013106	Sphingolipidoses
D020140	Lysosomal Storage Diseases, Nervous System
D020739	Brain Diseases, Metabolic, Inborn
D001928	Brain Diseases, Metabolic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010064	Embryo Implantation

Ancestor Terms

ID	Term
D047108	Embryonic Development
D005314	Embryonic and Fetal Development
D012098	Reproduction
D055703	Reproductive Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided