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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)
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Numbers of reconnected pulmonary veins (PV), with number and location of any gaps |
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Inclusion Criteria:
Exclusion Criteria:
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PAF population patients
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| Name | Affiliation | Role |
|---|---|---|
| Shaowen Liu, PhD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
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.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 |
| Mapping time | Procedural efficiency measures | 91-365 days |
| Contact force in grams | Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation | 91-365 days |
| Rate of adverse events occurred | Complications related to device or procedure | 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 | 91-365 days |
| Ablation time | Procedural efficiency measures | 91-365 days |
| Total procedure time | Procedural efficiency measures | 91-365 days |
| Fluid volume delivered via catheter | Procedural efficiency measures | 91-365 days |
| Ablation times in seconds | Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation | 91-365 days |
| Inter Tag in micrometers | Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation | 91-365 days |
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |