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

NCT ID: NCT03460535

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2019-06-30

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.

Conditions

Cardiac Arrhythmia; Cardiomyopathy, Dilated

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Group

UNKNOWN

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Maury, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe Maury, MD

Role: CONTACT

maury.p@chu-toulouse.fr

5 61 32 30 54 ext. 33

Isabelle Olivier, PhD

Role: CONTACT

olivier.i@chu-toulouse.fr

5 61 77 70 51 ext. 33

Facility Contacts

Philippe Maury, MD

Role: primary

maury.p@chu-toulouse.fr

5 61 32 30 54 ext. 33

Isabelle Olivier, PhD

Role: backup

olivier.i@chu-toulouse.fr

5 61 77 70 51 ext. 33

Other Identifiers

2017-A00777-46

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/16/8916

Identifier Type: -

Identifier Source: org_study_id