NCT03177018

Brief Summary

The main objective of this study is to assess if it is possible, at the end of endocardial voltage mapping, to accurately collect intact cardiomyocytes and to isolate high quality DNA allowing molecular testing of selected genes involved in arrhythmogenic right ventricular cardiomyopathy/dysplasia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

December 5, 2025

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

June 2, 2017

Last Update Submit

November 27, 2025

Conditions

Arrhythmogenic Right Ventricular CardiomyopathyArrhythmogenic Right Ventricular Dysplasia

Outcome Measures

Primary Outcomes (1)

  • percentage of patients

    Percentage of patients undergoing endocardial voltage mapping for arrhythmogenic right ventricular cardiomyopathy/dysplasia in whom at least one intact cardiomyocyte allowing extraction of high quality DNA will be collected.

    inclusion

Secondary Outcomes (5)

  • Mutation percentage

    Inclusion

  • DNA results

    Inclusion

  • Epigenetic analysis

    Inclusion

  • Cardiomyocytes number Description:

    Inclusion

  • Percentage of cardiomyocytes

    Inclusion

Study Arms (1)

Patients with Cardiomyocytes collection

EXPERIMENTAL

Patients suffering from arrhythmogenic right ventricular cardiomyopathy/dysplasia cardiac and needing endocardial voltage mapping for disease diagnosis and/or prognosis assessment

Diagnostic Test: Cardiomyocytes collection

Interventions

Cardiomyocytes collectionDIAGNOSTIC_TEST

collect intact cardiomyocytes from which high quality DNA extraction will be achieved

Patients with Cardiomyocytes collection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients needing endocardial voltage mapping in the context of arrhythmogenic right ventricular cardiomyopathy/dysplasia diagnosed using current criteria

You may not qualify if:

  • Patient under 18 years, pregnant women and patients under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiology-rytmology service

Paris, France

Location

University Hospital Toulouse - Cardiology Department

Toulouse, 31000, France

Location

Related Publications (1)

  • Maury P, Ader F, Lhuillier E, Martins F, Beneyto M, Gales C, Villard E, Duboscq-Bidot L, Gandjbakhch E, Guilbeau-Frugier C. Human DNA Extraction and Sequencing From Cardiomyocytes Collected by Catheter-Based Aspiration. J Am Coll Cardiol. 2024 Jul 30;84(5):490-492. doi: 10.1016/j.jacc.2024.05.037. No abstract available.

    PMID: 39048282RESULT

MeSH Terms

Conditions

Arrhythmogenic Right Ventricular Dysplasia

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesCardiomyopathiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Philippe MAURY, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Exploratory, monocentric and prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 6, 2017

Study Start

September 13, 2016

Primary Completion

February 23, 2018

Study Completion

December 31, 2018

Last Updated

December 5, 2025

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)