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

Toulouse University Hospital

Status: Unknown

Conditions: Cardiomyopathy, Dilated; Cardiac Arrhythmia

Study type: Observational

Funder types: Other

Identifiers

NCT03460535

2017-A00777-46 (Other Identifier)

RC31/16/8916

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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