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

Use of the Rhytmia System for Determining the Precise Location and Potential Mechanism of Premature Ventricular Contractions

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.

Study Overview

• Status: Unknown
• Conditions: Cardiomyopathy, Dilated; Cardiac Arrhythmia

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital Toulouse
    • Contact: Philippe Maury, MD; Phone Number: 33 5 61 32 30 54; Email: maury.p@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining the surface of optimal pace map or activation map	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.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record the local potentials at the site of PVC focus through the Rhythmia system	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.	One year
Determine the short success of the procedure	Determine by repeated Holter recordings, and the relation to the findings made during the procedure (endocardial or suspected epicardial focus), mechanism	One year
Determine long-term success of the procedure and compare it to the existing	Determine by repeated Holter recordings, and the relation to the findings made during the procedure (endocardial or suspected epicardial focus), mechanism	One year
Characterize optimal pace map or activation map as achieved by the Rhythmia system	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	One year

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Boston Scientific Group

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Rythmia system
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Arrhythmias, Cardiac; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: RC31/16/8916; 2017-A00777-46 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No