Clinical trial NCT03963349: THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
Official title: Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PAF population patients

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.

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

Primary outcomes:
measure: Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.
timeFrame: 91-365 days
Secondary outcomes:
measure: Rate of acute success at 0.5hour CPVI
timeFrame: 91-365 days
measure: Numbers of reconnected pulmonary veins (PV), with number and location of any gaps
timeFrame: 91-365 days
measure: Mapping time
timeFrame: 91-365 days
measure: Contact force in grams
timeFrame: 91-365 days
measure: Rate of adverse events occurred
timeFrame: 91-365 days
measure: Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year
timeFrame: 91-365 days
measure: Ablation time
timeFrame: 91-365 days
measure: Total procedure time
timeFrame: 91-365 days
measure: Fluid volume delivered via catheter
timeFrame: 91-365 days
measure: Ablation times in seconds
timeFrame: 91-365 days
measure: Inter Tag in micrometers
timeFrame: 91-365 days
measure: RF ablation and fluoroscopy times in seconds
timeFrame: 91-365 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shaowen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: