FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study (NCT03490201) | Clinical Trial Compass
CompletedNot Applicable
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
United States, Australia, Czechia592 participantsStarted 2018-06-01
Plain-language summary
This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.
Who can participate
Age range
18 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:
* Structural heart disease (ischemic or non-ischemic) with one of the following:
* Confirmed diagnosis via echocardiography and/or cardiac CT/MRI \[computed tomography/magnetic resonance imaging\], or
* Left ventricular ejection fraction (EF) \<40% (documented within the last 6 months via echocardiography, or
* Arrhythmogenic RV \[right ventricular\] cardiomyopathy/dysplasia (per 2010 ARVC/D \[arrhythmogenic right ventricular cardiomyopathy/dysplasia\] Task Force Criteria).27
* At least one documented episode of sustained MMVT by either EGM \[cardiac electrogram\] or ECG \[electrocardiogram\] in the 6 months prior to enrollment
* Implanted with a market released ICD \[implantable cardioverter-defibrillator\] or CRT-D \[cardiac resynchronization therapy-defibrillator\] for at least 30 days prior to index ablation procedure
* Refractory (i.e. not effective, not tolerated or not desired) to at least one anti-arrhythmic medication (either amiodarone or sotalol) for treatment of MMVT
* At least 18 years of age
* Informed of the nature of the study, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical study site.
* Able and willing to comply with all study requirements
Exclusion Criteria:
* Implanted with a subcutaneous ICD
* Implanted with a ventricular assist device (VAD) (e.g. TandemHeart)
* Currently receiving support, or anticipated to …
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.