Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone with the NOGA System

NCT04757168 | Recruiting

• 1 other identifier: RC31/19/0513
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Despite a decrease in voltage amplitude in post-infarction scar areas, greater voltage amplitudes are sometimes observed at the time of local extrasystoles mechanically induced by catheters. However, no study has investigated whether these electrical changes are associated with mechanical changes in local contractility. However, the voltage is closely correlated to the local contractile function as evidenced by the use of the NOGA system.

Conditions

Myocardial Infarction

Keywords

stimulation in cardiac scar area

Outcome Measures

Primary Outcomes (1)

• Evolution of LLS (linear local shortening) via the NOGATM system in percentage

  Study the change in percentage of LLS during stimulation in a post-infarction scar zone identified by voltage mapping of the left ventricle with the NOGA system, compared to LLS in the same zone measured in atrial stimulation

  1month

Secondary Outcomes (3)

• Evolution of global systolic function: left ventricular ejection fraction

  1month

• Evolution of the global systolic function: integral time velocity under aortic Translation results Evolution of the global systolic function: integral time velocity under aortic

  1month

• Evolution of the global systolic function: strain longitudinal global

  1month

Study Arms (1)

NOGA TM probe

EXPERIMENTAL

Device: NOGA TM probe

Interventions

NOGA TM probe DEVICE

Each subject will be his own witness since the linear local shortening (LLS) will be measured successively in all patients before, then after stimulation of the scar zone (comparison of LLS measured in sinus rhythm then during stimulation in the scar zone for each patient. Each subject being his own witness and the two recordings being made a few minutes apart, during the same procedure.

NOGA TM probe

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients who should undergo ventricular tachycardia (VT) ablation after a myocardial infarction according to current recommendations, namely: patients with ischemic heart disease (ICD) and with episodes of sustained ventricular tachycardia responsible for internal electric shocks by the implantable automatic defibrillator (ICD) (grade IB recommendation)
• patients with an MIC and an ICD, presenting a first episode of sustained ventricular tachycardia (grade IIa, B recommendation)
• Affiliated with a social protection scheme
• Having signed an informed consent

You may not qualify if:

• Contraindication or non-indication for ventricular tachycardia ablation
• Women who are pregnant or of childbearing age and without contraception, breastfeeding women
• Patients without ischemic heart disease
• Patients under guardianship, curatorship or legal protection.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

ROLLIN Anne

Toulouse, CHU de Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Anne ROLLIN, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne ROLLIN, MD

CONTACT

5 61 32 24 29; rollin.a@chu-toulouse.fr

Philippe MAURY, MD

CONTACT

5 61 34 10 18; maury.p@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 17, 2021
• Study Start: February 23, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)