THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

Active, not recruiting

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT03963349
• Lead Sponsor: Biosense Webster, Inc.

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.

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Study Start: 2019-06-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Fluid volume delivered via catheter	91-365 days	Procedural efficiency measures
Mapping time	91-365 days	Procedural efficiency measures
Ablation times in seconds	91-365 days	Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
Rate of acute success at 0.5hour CPVI	91-365 days	Entrance block rate achieved by all pulmonary veins after 0.5hour waiting time and isoproterenol challenge after CPVI
Contact force in grams	91-365 days	Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year	91-365 days	Rate of patients who are back to hospital and got hospitalized due to AF/AT/AFL recurrence or procedure-related reasons during 91 to 365 days after procedure
Total procedure time	91-365 days	Procedural efficiency measures
Inter Tag in micrometers	91-365 days	Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
Numbers of reconnected pulmonary veins (PV), with number and location of any gaps	91-365 days	Numbers of pulmonary veins recovered after 0.5hour waiting time and isoproterenol challenge after CPVI, and the location of recovery and number are also recorded
Ablation time	91-365 days	Procedural efficiency measures
Rate of adverse events occurred	91-365 days	Complications related to device or procedure
RF ablation and fluoroscopy times in seconds	91-365 days	Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China