NCT03963349Active, not recruiting
THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 6 May 2019
- Start date
- 24 Jun 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT03963349
What you commit to
- Study type: Observational
- Planned participants: 150
- From 24 Jun 2019 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of heart surgery, or any previous ablation for AF
- Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
- Enrollment in an investigational study evaluating another device, biologic, or drug
Other illness
- AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
- Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
- New York Heart Association (NYHA) class III or IV heart failure
Other
- Patient has AF episodes lasting longer than 7 days
- Documented left atrial thrombus on imaging
- Hypertrophic obstructive cardiomyopathy
- Presence of implantable cardioverter defibrillator (ICD)
- Contraindication to isoproterenol
- Women who are pregnant and/or breast feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.