Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Active, not recruiting Observational

THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

NCT03963349 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2019-06-24
Last updated
2026-11-03

Condition(s) studied

Paroxysmal Atrial Fibrillation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 years or older 2. Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment 3. Able and willing to comply with all pre-, post- and follow-up testing and requirements 4. Able to sign EC-approved informed consent form Exclusion Criteria: 1. AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause 2. Patient has AF episodes lasting longer than 7 days 3. History of heart surgery, or any previous ablation for AF 4. Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months 5. Documented left atrial thrombus on imaging 6. New York Heart Association (NYHA) class III or IV heart failure 7. Hypertrophic obstructive cardiomyopathy 8. Presence of implantable cardioverter defibrillator (ICD) 9. Contraindication to isoproterenol 10. Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator 11. Women who are pregnant and/or breast feeding 12. Enrollment in an investigational study evaluating another device, biologic, or drug

Primary outcome measure(s)

  • Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure. — 91-365 days
    Atrial tachyarrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.

Trial sites (1)

FacilityCityRegionStatus
Shanghai General Hospital Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03963349 on ClinicalTrials.gov ↗ ← All trials in China