THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

NCT03963349 | Active Not Recruiting

• 1 other identifier: BWI-2018-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (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.

  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.

  91-365 days

Secondary Outcomes (12)

• Rate of acute success at 0.5hour CPVI

  91-365 days

• Numbers of reconnected pulmonary veins (PV), with number and location of any gaps

  91-365 days

• Mapping time

  91-365 days

• Contact force in grams

  91-365 days

• Rate of adverse events occurred

  91-365 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PAF population patients

You may qualify if:

• 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

You may not qualify if:

• 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)
• Contraindication to isoproterenol
• Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
• Women who are pregnant and/or breast feeding
• Enrollment in an investigational study evaluating another device, biologic, or drug

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaowen Liu, PhD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 24, 2019
• Study Start: June 24, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)