Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone With the NOGA System (SCARPACE)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Device: NOGA TM probe

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne ROLLIN, MD; Phone Number: +33 5 61 32 24 29; Email: rollin.a@chu-toulouse.fr
• Study Contact Backup: Name: Philippe MAURY, MD; Phone Number: +33 5 61 34 10 18; Email: maury.p@chu-toulouse.fr

Study Locations

• France
  • CHU De Toulouse
    • Toulouse Cedex 9, CHU De Toulouse, France, 31059
      • Recruiting
      • ROLLIN Anne
      • Contact: Anne ROLLIN; Email: rollin.a@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 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)

OR

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NOGA TM probe

Device: NOGA TM probe; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of global systolic function: left ventricular ejection fraction	Compare the left ventricular ejection fraction (in percentage) during stimulation in a scar area compared to a normal rhythm	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	Compare the integral time velocity under aortic (in centimeter) during stimulation in a scar area compared to a normal rhythm	1month
Evolution of the global systolic function: strain longitudinal global	Compare the strain longitudinal global(in percentage) during stimulation in a scar area compared to a normal rhythm	1month

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Anne ROLLIN, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: stimulation in cardiac scar area
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: RC31/19/0513

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
• product manufactured in and exported from the U.S.: No