THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study (NCT03963349) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
China150 participantsStarted 2019-06-24
Plain-language summary
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.
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
. Age 18 years or older
. Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment
. Able and willing to comply with all pre-, post- and follow-up testing and requirements
. Able to sign EC-approved informed consent form
Exclusion criteria
. AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
. Patient has AF episodes lasting longer than 7 days
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 study is measuring whether patients stay free from AF, atrial tachycardia, or atrial flutter for at least 30 seconds between 3 and 12 months after the ablation procedure — how does my own AF pattern and history compare to the patients enrolled in this study, and does that affect whether these results would be meaningful for my situation?
2Since this trial is listed as 'active not recruiting,' I can't join it — but based on what it's studying about the ThermoCool SmartTouch SF catheter and Ablation Index technology, is this the type of ablation approach you would use for me, and what does the emerging data suggest about its effectiveness compared to older ablation methods?
3Ablation is one path for paroxysmal AF, but are there standard treatments or other proven options I should try first before considering any ablation procedure, and how would you weigh those against what studies like this one are exploring?
4This trial tracks freedom from irregular heart rhythms for up to a year after the procedure — what happens after that one-year window, and how durable are the results of catheter ablation for paroxysmal AF typically expected to be over the longer term?
5What are the main risks associated with catheter ablation procedures like the one studied here, and given that this is a Phase NA study focused on measuring outcomes rather than establishing basic safety, what does that tell us about how well-understood the safety profile of this catheter already is?
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
Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.