The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are:

• Atrial-esophageal fistula
• AV block
• Cardiac Perforation/ Tamponade
• Death
• Diaphragmatic paralysis
• Gastroparesis
• Hospitalization
• Myocardial Infarction
• Pericarditis
• Pneumothorax
• Pulmonary edema
• Pulmonary vein stenosis
• Stroke
• Thromboembolism
• Transient ischemic attack
• Vascular access complications

Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur >7 days post procedure through 30 days will also contribute to the primary endpoint.

All subjects with device inserted into vasculature and either experienced a primary endpoint event or completed 30 days of follow up.

The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins

Effectiveness Population - all subjects with device inserted into vasculature

This outcome is the average power delivered for a case.

The population includes only subjects with at least some radiofrequency energy delivered.

Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force

Population includes all subjects with at least some radiofrequency energy delivered.

Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.

Population includes all subjects with ablation catheter inserted.

Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation

Subjects with TactiCath SE inserted into vasculature

One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.

Includes subjects with the following:

• device inserted
• RF energy delivered
• Had 12M visit or failed endpoint

One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.

The analysis population included the following subjects:

• Device inserted
• Radiofrequency energy applied
• 12M visit complete or failed endpoint

Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement.

Subset of RF population with EQ-5D-5L data at both baseline and 12M

Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.

Subjects in RF population with available AFEQT data at both baseline and 12M

Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up.

Subjects with device inserted and healthcare utilization data reported

Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated.

Subjects from RF population with FTI or LSI data available

This outcome is the average temperature (by lesion) for a case.

The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is whether or not the recommended irrigation flow rate was used for a case.

The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the average contact force for a case.

The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the total procedure time for a case.

The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the total ablation time for a case. This is the time from first to last ablation.

The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the total fluoroscopy time for a case.

The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the total RF application time for a case.

The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the number of cases using AutoMark.

The population includes only subjects with at least some radiofrequency energy delivered.

Mean lesion index (LSI) across lesions by subject

Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application.

Subjects from RF population with some LSI data available