The Rhytmia System to Determine the Precise Location and Potential Mechanism of Premature Contractions

• Conditions: Cardiac Arrhythmia; Cardiomyopathy, Dilated

• Registration Number: NCT03460535
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

This is a purely observational project and the objectives are to record and analyze the local potentials at the site of Premature Ventricular Contraction (VPC) focus through the Rhythmia system, ti determine the short and long-term success of the procedure and compare it to the existing literature about standard procedures, to highlight the advantages of the system compared to conventional mapping and to characterize optimal pace map or activation map as achieved by the Rhythmia system.

Detailed Description

This is a purely observational study. No special methodology choice, no comparison.

The study want to find the determination of precise location of the focus and mechanisms involved constitutes a challenge for conventional electrophysiology, even with tridimensional systems, because of the time needed for accurate delineation of the location (due to the sometimes unfrequent Ventricular Premature Beats (VPB)) and to the insufficient mapping density or inadequate signal characteristics. The Rhythmia system could allow better determination of the focus location in relation to the anatomical structures, especially with unfrequent VPB, because of the available high density mapping due to the number of closed high-resolution electrodes located on the Orion catheter. Better delineation of the true focus origin and of the mechanisms involved (automaticity vs re-entry) may be of useful help for better understanding and efficient therapy.

Study Timeline

• Study Start: 2017-06-14
• Study First Submitted: 2018-02-26
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-07
• Last Update Submitted: 2018-03-07
• Study First Posted: 2018-03-09
• Last Update Posted: 2018-03-09
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients with symptomatic monomorphic PVC with or without heart disease refractory to anti arrhythmic drugs
• patients with dilated cardiomyopathy and altered Left Ventricular Ejection Fraction (LVEF) suspected to be causes by frequent monomorphic VPC
• patients with malignant ventricular arrhythmias reproducibly induced by monomorphic PVC

Exclusion Criteria

• patients with non-symptomatic VPC and without cardiomyopathy
• patients under 18 yo
• pregnant women
• patients with polymorphic PVC arising from clearly different areas
• patient protected by the french law: guardianship and Trusteeship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining the surface of optimal pace map or activation map	One year	To evaluate the area of isochronal earliest activation of PVC (Premature Ventricular Contraction), based on unipolar or bipolar activation : correlations will be made with the suspected endocardial or epicardial/intra-mural location of the focus. This technic may reduce the area of perfect pace-mapping and possibly more accurately locate the focus.

Secondary Outcome Measures

Name	Time	Method
Characterize optimal pace map or activation map as achieved by the Rhythmia system	One year	Evaluate the surface of perfect pace-mapping using the Orion catheter, by pacing from any electrode being in close contact with the endocardial surface and comparing the paced QRS to a template of the spontaneous VPC
Determine the short success of the procedure	One year	Determine by repeated Holter recordings, and the relation to the findings made during the procedure (endocardial or suspected epicardial focus), mechanism
Record the local potentials at the site of PVC focus through the Rhythmia system	One year	Pacing from any electrode being in close contact with the endocardial surface and comparing the paced QRS to the spontaneous VPC (automatic calculation available on Bard ElectroPhysiology (EP) system).; Describe and analyze the local signals recorded from the Orion catheter at the site of the PVC focus.; by looking for prepotentials as a surrogate of local abnormal automaticity, for local discrete scar and local late potentials favouring local reentry as a cause for PVC, determining the local activation characteristics of VPC (surface of local breakthrough, velocity and direction of activation.
Determine long-term success of the procedure and compare it to the existing	One year	Determine by repeated Holter recordings, and the relation to the findings made during the procedure (endocardial or suspected epicardial focus), mechanism

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France