THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study (STSF)

• ClinicalTrials.gov Identifier: NCT03963349
• Recruitment Status: Active, not recruiting
• First Posted: May 24, 2019
• Last Update Posted: March 22, 2023
• Sponsor: Biosense Webster, Inc.
• Information provided by (Responsible Party): Biosense Webster, Inc.

Study Description

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.

Condition or disease
Paroxysmal Atrial Fibrillation

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 150 participants
• Observational Model: Other
• Time Perspective: Other
• Target Follow-Up Duration: 1 Year
• Official Title: Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index
• Actual Study Start Date: June 24, 2019
• Estimated Primary Completion Date: March 31, 2023
• Estimated Study Completion Date: March 31, 2023

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: 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 :

1. Rate of acute success at 0.5hour CPVI [ Time Frame: 91-365 days ]
   Entrance block rate achieved by all pulmonary veins after 0.5hour waiting time and isoproterenol challenge after CPVI
2. Numbers of reconnected pulmonary veins (PV), with number and location of any gaps [ Time Frame: 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
3. Mapping time [ Time Frame: 91-365 days ]
   Procedural efficiency measures
4. Contact force in grams [ Time Frame: 91-365 days ]
   Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
5. Rate of adverse events occurred [ Time Frame: 91-365 days ]
   Complications related to device or procedure
6. Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year [ Time Frame: 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
7. Ablation time [ Time Frame: 91-365 days ]
   Procedural efficiency measures
8. Total procedure time [ Time Frame: 91-365 days ]
   Procedural efficiency measures
9. Fluid volume delivered via catheter [ Time Frame: 91-365 days ]
   Procedural efficiency measures
10. Ablation times in seconds [ Time Frame: 91-365 days ]
    Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
11. Inter Tag in micrometers [ Time Frame: 91-365 days ]
    Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
12. RF ablation and fluoroscopy times in seconds [ Time Frame: 91-365 days ]
    Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

PAF population patients

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

Contacts and Locations

Locations

China, Shanghai

Shanghai General Hospital

Shanghai, Shanghai, China, 200080

Sponsors and Collaborators

Biosense Webster, Inc.

Investigators

• Principal Investigator: Shaowen Liu, PhD; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

More Information

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT03963349
• Other Study ID Numbers: BWI-2018-01
• First Posted: May 24, 2019
• Last Update Posted: March 22, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
• URL: http://yoda.yale.edu.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes