THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

Paroxysmal Atrial Fibrillation Clinical Trial

— STSF  

Official title:

Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03963349
• Other study ID #: BWI-2018-01
• Status: Active, not recruiting
• Start date: June 24, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	91-365 days
Secondary	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	91-365 days
Secondary	Mapping time	Procedural efficiency measures	91-365 days
Secondary	Contact force in grams	Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation	91-365 days
Secondary	Rate of adverse events occurred	Complications related to device or procedure	91-365 days
Secondary	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	91-365 days
Secondary	Ablation time	Procedural efficiency measures	91-365 days
Secondary	Total procedure time	Procedural efficiency measures	91-365 days
Secondary	Fluid volume delivered via catheter	Procedural efficiency measures	91-365 days
Secondary	Ablation times in seconds	Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation	91-365 days
Secondary	Inter Tag in micrometers	Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation	91-365 days
Secondary	RF ablation and fluoroscopy times in seconds	Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation	91-365 days