LSI (Lesion Index) Workflow Observational Study

Study Overview
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Brief Summary
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This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-word environment.

Detailed Description
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The primary objective of this study is to characterize LSI achieved values for durable lesion formation using the TactiCath SE catheter in the different anatomical regions around the pulmonary veins (PVs) of the heart during RF ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF) Secondary objectives of this study are as follows: To characterize the use of EnSite Automap and AutoMark module software settings, including LSI threshold (OUS), contact force, time, power, flow, and AutoMark spacing using the TactiCath SE catheter for RF ablation for the treatment of drug-refractory PAF. To characterize LSI achieved values for lesions that reconnected versus those that were durable, both in an acute procedural setting as well as in patients who undergo additional ablations during the 12-month follow-up period after an index RF ablation procedure for the treatment of drug-refractory PAF.

Official Title
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LSI (Lesion Index) Workflow Post-Market Observational Study

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must provide written informed consent prior to any clinical investigation related procedure. Subject is at least 18 years of age. Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule. Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation. Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug. For the purposes of this study, intolerant includes either: Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason. Subject was offered the drug and refused to take for any reason. Exclusion Criteria: Previous ablation or surgery in the left atria. Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable). Participation in another clinical investigation that may confound the results of this study. Pregnant or nursing. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. Life expectancy less than 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Radiofrequency Ablation|The Tacticath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) is designed to facilitate electrophysiological mapping of the heart chambers and to transmit radiofrequency (RF) current to the catheter tip electrode for intracardiac ablation purposes.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary LSI-Achieved Value Endpoint | The primary endpoint is a summary of LSI values achieved for RF lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). | At time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ensite AutoMap and AutoMark settings | Descriptive summary of EnSite AutoMap and AutoMark module software settings, including LSI threshold settings (in OUS), contact force, time, power, flow settings, and AutoMark spacing for each procedure | At time of procedure | 
| Electic Isolation of Pulmonary Veins | Acute electrical isolation of PVs, 20 minutes after last RF ablation in PV region | 20 minutes after last RF ablation in PV region | 
| 7-Day Device or Procedure related SAE rate | Device- or procedure-related SAEs within 7-days and 12-months of index procedure | within 7-days of index procedure | 
| 12-Month Device or Procedure related SAE rate | Device- or procedure-related SAEs within 7-days and 12-months of index procedure | within 12-months of index procedure | 
| Freedom from AF/AFL/AT recurrence | Freedom from documented AF/AFL/AT recurrence at 12-months post index ablation, excluding a 90-day blanking period | No documented episodes greater than 30 seconds with a 24hour-Holter | 
| Repeat Ablation Proportion | Proportion of patients with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period) | 12-months post index procedure (excluding 90-day blanking period) | 
| First-pass PVI lesion | Proportion of lesions generated during first-pass PVI that required touch-up ablation | At time of procedure | 
| Touch-up ablation of pulmonary viens | Proportion of pulmonary veins (PVs) requiring touch-up ablation | At time of procedure | 
| Index procedure touch-up ablations | Proportion of patients who required at least one touch-up ablation during the index procedure | At time of procedure | 
| LSI achieved values for repeat RF ablations | In patients who undergo any repeat RF ablation procedures up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable | up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable | 
| Overall procedure time | Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations | At time of procedure | 
| Overall RF ablation time | Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, and any touch-up ablations | At time of procedure | 
| Overall fluro time | Overall fluoroscopy time | At time of procedure | 
| Quality of life changes 6-Month | Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-months post index ablation, compared to baseline scores | 6 months post index ablation, compared to baseline scores | 
| Quality of life changes 12-Month | Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-months post index ablation, compared to baseline scores | 12-months post index ablation, compared to baseline scores | 
| Antiarrhythmia medication | AAD use at 12-months | 12-months | 
| Health care utilization | Health care utilization (including number of unscheduled hospital outpatient/ER visits and inpatient hospitalizations due to arrhythmias) collected throughout the 12-month follow-up period | collected throughout the 12-month follow-up period |