Back to results

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

Primary Purpose

Myocardial Infarction

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

NOGA TM probe

About this trial

This is an interventional other trial for Myocardial Infarction focused on measuring stimulation in cardiac scar area

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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.

Sites / Locations

ROLLIN AnneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NOGA TM probe

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT04757168

First Posted

February 4, 2021

Last Updated

July 21, 2023

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT04757168

Brief Title

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

Acronym

SCARPACE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 23, 2022 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

stimulation in cardiac scar area

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NOGA TM probe

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

NOGA TM probe

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1month

Secondary Outcome Measure Information:

Title

Evolution of global systolic function: left ventricular ejection fraction

Description

Compare the left ventricular ejection fraction (in percentage) during stimulation in a scar area compared to a normal rhythm

Time Frame

1month

Title

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

Description

Compare the integral time velocity under aortic (in centimeter) during stimulation in a scar area compared to a normal rhythm

Time Frame

1month

Title

Evolution of the global systolic function: strain longitudinal global

Description

Compare the strain longitudinal global(in percentage) during stimulation in a scar area compared to a normal rhythm

Time Frame

1month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne ROLLIN, MD

Phone

5 61 32 24 29

Ext

+33

rollin.a@chu-toulouse.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe MAURY, MD

Phone

5 61 34 10 18

Ext

+33

maury.p@chu-toulouse.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne ROLLIN, MD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

ROLLIN Anne

City

Toulouse Cedex 9

State/Province

CHU De Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne ROLLIN

rollin.a@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs