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

NCT03460535 | Unknown

• 2 other identifiers: RC31/16/89162017-A00777-46
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmia; Cardiomyopathy, Dilated

Keywords

Rythmia system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Record the local potentials at the site of PVC focus through the Rhythmia system

  One year

• Determine the short success of the procedure

  One year

• Determine long-term success of the procedure and compare it to the existing

  One year

• Characterize optimal pace map or activation map as achieved by the Rhythmia system

  One year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Boston Scientific Group: collaborator

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Philippe Maury, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Maury, MD

CONTACT

5 61 32 30 54; maury.p@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

5 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 9, 2018
• Study Start: June 14, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 9, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)