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 range18 Years

SexALL

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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
✕. History of heart surgery, or any previous ablation for AF
✕. Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
✕. Documented left atrial thrombus on imaging
✕. New York Heart Association (NYHA) class III or IV heart failure
✕. Hypertrophic obstructive cardiomyopathy
✕. Presence of implantable cardioverter defibrillator (ICD)

What they're measuring

Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.

Timeframe: 91-365 days

Trial details

NCT IDNCT03963349

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation trials