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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Device: NOGA TM probe

• Registration Number: NCT04757168
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Study Start: 2022-02-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NOGA TM probe	NOGA TM probe	-

Primary Outcome Measures

Name	Time	Method
Evolution of LLS (linear local shortening) via the NOGATM system in percentage	1month	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ROLLIN Anne; 🇫🇷 Toulouse Cedex 9, CHU de Toulouse, France