Myocardial InfarctionSCARPACENCT04757168
Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone With the NOGA System
A study testing NOGA TM probe in people with Myocardial Infarction, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- NOGA TM probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2022to 26 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myocardial Infarction
- Being tested
- NOGA TM probe
- Keywords
- stimulation in cardiac scar area
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOGA TM probeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NOGA TM probe | Experimental | Not described Receives: Device: NOGA TM probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1month
Secondary outcomes (3)
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
Measured: 1month
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
Measured: 1month
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
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start23 Feb 2022
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne ROLLIN, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757168
- Sponsor's protocol ID
- RC31/19/0513
- Acronym
- SCARPACE
- Status last verified
- May 2026
- First submitted
- 4 Feb 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone With the NOGA System
- ClinicalTrials.gov ID
- NCT04757168
- Acronym / sponsor ID
- SCARPACE / RC31/19/0513
- Conditions
- Myocardial Infarction
- Keywords
- stimulation in cardiac scar area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOGA TM probe | Experimental | Device: NOGA TM probe |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOGA TM probeEach 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. | Device | NOGA TM probe |
Primary outcome
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
3 secondary outcomes
Evolution of global systolic function: left ventricular ejection fraction
Time frame: 1month
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
Evolution of the global systolic function: strain longitudinal global
Time frame: 1month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne ROLLIN, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOGA TM probe in people with Myocardial Infarction, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of LLS (linear local shortening) via the NOGATM system in percentage (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.