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

Cardiac Arrhythmia Clinical Trial

— RhytmiaPVC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03460535
• Other study ID #: RC31/16/8916
• Secondary ID: 2017-A00777-46
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 7, 2018
• Start date: June 14, 2017
• Est. completion date: June 2019

Study information

• Verified date: March 2018
• Source: University Hospital, Toulouse
• Contact: Philippe Maury, MD
• Phone: 5 61 32 30 54
• Email: maury.p[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Ventricular Premature Complexes

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Boston Scientific Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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