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

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ClinicalTrials.gov Identifier: NCT04757168
Recruitment Status : Not yet recruiting
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Device: NOGA TM probe Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone With the NOGA System
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04757168


Contacts
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Contact: Anne ROLLIN, MD 5 61 32 24 29 ext +33 rollin.a@chu-toulouse.fr
Contact: Philippe MAURY, MD 5 61 34 10 18 ext +33 maury.p@chu-toulouse.fr

Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Anne ROLLIN, MD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04757168    
Other Study ID Numbers: RC31/19/0513
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University Hospital, Toulouse:
stimulation in cardiac scar area
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases