Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone With the NOGA… (NCT04757168) | Clinical Trial Compass
CompletedNot Applicable
Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone With the NOGA System
France10 participantsStarted 2022-02-23
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used the NOGA mapping system to stimulate scar tissue in the heart after a heart attack — can you explain what that kind of stimulation actually involves, and whether anything like it might be relevant to my situation?
2Since the main thing this study measured was something called 'linear local shortening' in the scarred area of the heart, what does that measurement tell us about how well the heart muscle is actually recovering, and would my heart be assessed in a similar way?
3This trial has already been completed — have any results been published yet, and if so, do they show any meaningful changes in how the heart contracts in the scar zone that might be worth considering for my care?
4Because this study didn't have a standard phase label, it may have been more exploratory than a typical treatment trial — does that mean the approach is still early-stage, and how does that compare to standard treatments available to me right now?
5Given that this trial focused specifically on patients with myocardial infarction and scar tissue, how would you determine whether the area of my heart affected by my heart attack would even be a candidate for this type of NOGA-based evaluation or stimulation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evolution of LLS (linear local shortening) via the NOGATM system in percentage