THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

N/AActive Not RecruitingNCT03963349

Biosense Webster, Inc.150 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

Paroxysmal Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 91-365 days

Secondary Outcomes

Rate of acute success at 0.5hour CPVI

Entrance block rate achieved by all pulmonary veins after 0.5hour waiting time and isoproterenol challenge after CPVI

Time frame: 91-365 days

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

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

Time frame: 91-365 days

Mapping time

Procedural efficiency measures

Time frame: 91-365 days

Contact force in grams

Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation

Time frame: 91-365 days

Rate of adverse events occurred

Complications related to device or procedure

Time frame: 91-365 days

Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year

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

Data from ClinicalTrials.gov

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