Clinical trial NCT03460535: The Rhytmia System to Determine the Precise Location and Potential Mechanism of Premature Contractions
Official title: Use of the Rhytmia System for Determining the Precise Location and Potential Mechanism of Premature Ventricular Contractions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmia
Cardiomyopathy, Dilated
Keywords: Rythmia system
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Boston Scientific Group
First posted: 2018-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited by consultations, hospitalisations or referral by external doctors, in the department of Cardiology.

This is a purely observational study. No power calculation will be needed due to the lack of comparisons.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determining the surface of optimal pace map or activation map
timeFrame: One year
Secondary outcomes:
measure: Record the local potentials at the site of PVC focus through the Rhythmia system
timeFrame: One year
measure: Determine the short success of the procedure
timeFrame: One year
measure: Determine long-term success of the procedure and compare it to the existing
timeFrame: One year
measure: Characterize optimal pace map or activation map as achieved by the Rhythmia system
timeFrame: One year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Philippe Maury, MD
role: PRINCIPAL_INVESTIGATOR
References: