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

Myocardial Infarction Clinical Trial

— SCARPACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757168
• Other study ID #: RC31/19/0513
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Anne ROLLIN, MD
• Phone: 5 61 32 24 29
• Email: rollin.a[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
France	ROLLIN Anne	Toulouse Cedex 9	CHU De Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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