THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

NCT ID: NCT03963349

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2026-06-30

Brief 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.

Detailed Description

The purpose of this study is to measure the long term effectiveness，clinical benefit, and safety outcomes of catheter ablation with STSF and AI for paroxysmal atrial fibrillation (PAF) subjects up to 12-month follow-up.

Subject:Up to 150 PAF subjects will be included in the study data, representing all consecutive subjects having catheter ablation with AI guiding STSF and for the treatment of PAF at the site.

Primary endpoint: The primary endpoint is freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.

Secondary endpoint : Acute success at 0.5hour CPVI (i.e. entrance block achieved in all veins, verified via an isoproterenol intravenous challenge)

• Numbers of reconnected pulmonary veins (PV), with number and location of any gaps
• Procedural efficiency measures（e.g. mapping time, ablation time, total procedure time, and fluid volume delivered via catheter.
• AI values
• Inter-Tag distances
• Adverse events (Complications related to device or procedure)
• Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year Clinical Study Sites: Shanghai General Hospital Study Duration: 18-month enrollment period, with follow-up at 3, 6 and 12 months after ablation, with a blanking period defined as the period within 90 days after the ablation.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaowen Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

BWI-2018-01

Identifier Type: -

Identifier Source: org_study_id