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OpenTrials
Completed

NCT Number: NCT04757168

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ROLLIN Anne

Toulouse, CHU de Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Evolution of global systolic function: left ventricular ejection fraction

    Time frame: 1month

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

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

    Time frame: 1month

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

  3. Evolution of the global systolic function: strain longitudinal global

    Time frame: 1month

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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: SCARPACE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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