Paroxysmal Atrial Fibrillation
Conditions
Brief summary
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit.
Detailed description
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit. The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of Tag Index-guided ablation using the VISITAG SURPOINT™ Module with External Processing Unit when used with the THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheters for pulmonary vein isolation (PVI) in the treatment of subjects with drug refractory symptomatic paroxysmal atrial fibrillation. Specifically: * To demonstrate the safety based on the proportion of subjects with early-onset (within 7 days of ablation procedure) primary adverse events * To demonstrate the 12-month effectiveness based on the proportion of subject with freedom from documented atrial arrhythmia (atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) episodes during the effectiveness evaluation period (Day 91-365)
Interventions
DEVICECatheter ablation with EPU
Subjects undergoing electrophysiology mapping and RF ablation with THERMOCOOL SMARTTOUCH ® SF (STSF) and THERMOCOOL SMARTTOUCH ® (ST) catheters with VISITAG SURPOINT Module with External Processing Unit for pulmonary vein isolation
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Symptomatic paroxysmal AF who had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip 2. Failed at least one antiarrhythmic drug (AAD) (Class I or III antiarrhythmic drugs) as evidenced by recurrent symptomatic AF, or intolerable to the AAD 3. Age 18 years or older 4. Signed Patient Informed Consent Form (ICF) 5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Primary Adverse Events (PAEs) | Up to 12 months | A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic) | Up to 12 months | Number of participants free from symptomatic and asymptomatic atrial tachyarrhythmias (which includes atrial fibrillation \[AF\], atrial flutter \[AFL\], and atrial tachycardia \[AT\]) were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Non-Primary AEs | Up to 12 months | Serious non-primary adverse events were defined as serious AEs (SAEs) that are not primary adverse events. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months) | Number of participants with bleeding complication by ISTH class and timing of onset were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (\>=) 2 grams per deciliter (g/dL), transfusion of \>= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events. |
| Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure | End of the Procedure (up to 12 months) | Percentage of participants with ipsilateral PVI (entrance block) at the end of the procedure were reported. |
| Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection | Up to 12 months | Percentage of participants with ipsilateral PVI after first encirclement without Acute reconnection was reported. |
| Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins | Up to 12 months | Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins was reported. |
| Percentage of Participants With Cumulative PAEs | Up to 12 months | A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Number of Participants Who Underwent Repeat Ablation Procedures | Up to 12 months | Number of participants who underwent repeat ablation procedures were reported. |
| Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure | Up to 12 months | Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure was reported. |
| Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure | Up to 12 months | Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure was reported. |
| Percentage of Participants With 12-Month Single Procedure Success | Up to 12 months | Percentage of participants with 12-month single procedure success was reported. It is defined as freedom from 1) any repeat procedure for Atrial fibrillation (AF)/Atrial tachycardia (AT)/Atrial flutter (AFL) post index procedure; 2) any class I/III AAD taking during the evaluation period; 3) documented AF/AT/AFL recurrence in evaluation period. |
| Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | Up to 12 months | Percentage of targeted veins with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). |
| Number of Participants With Unanticipated Adverse Device Effects (UADEs) | Up to 12 months | Number of participants with UADEs was reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU). | 261 |
| VISITAG SURPOINT Module ST Catheter With EPU Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU. | 49 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Catheter Inserted and RF Energy Delivery with No EPU System Used | 2 | 0 |
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 10 | 4 |
| Overall Study | No Catheter Inserted | 6 | 1 |
| Overall Study | Screen Failure | 14 | 0 |
| Overall Study | Withdrawal by Subject | 12 | 1 |
Baseline characteristics
| Characteristic | VISITAG SURPOINT Module STSF Catheter With EPU | Total | VISITAG SURPOINT Module ST Catheter With EPU |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 10.53 | 63.4 years STANDARD_DEVIATION 10.25 | 62.7 years STANDARD_DEVIATION 9.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 19 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 231 Participants | 267 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 24 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 11 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants | 33 Participants | 9 Participants |
| Race (NIH/OMB) White | 221 Participants | 258 Participants | 37 Participants |
| Sex: Female, Male Female | 109 Participants | 136 Participants | 27 Participants |
| Sex: Female, Male Male | 152 Participants | 174 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 261 | 0 / 49 |
| other Total, other adverse events | 139 / 261 | 24 / 49 |
| serious Total, serious adverse events | 53 / 261 | 6 / 49 |
Outcome results
Primary
Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic)
Number of participants free from symptomatic and asymptomatic atrial tachyarrhythmias (which includes atrial fibrillation \[AF\], atrial flutter \[AFL\], and atrial tachycardia \[AT\]) were reported.
Time frame: Up to 12 months
Population: The Per-protocol (PP) set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic) | 173 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic) | 34 Participants |
Primary
Number of Participants With Primary Adverse Events (PAEs)
A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 12 months
Population: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Primary Adverse Events (PAEs) | 11 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Primary Adverse Events (PAEs) | 3 Participants |
Secondary
Number of Participants Who Underwent Repeat Ablation Procedures
Number of participants who underwent repeat ablation procedures were reported.
Time frame: Up to 12 months
Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants Who Underwent Repeat Ablation Procedures | 14 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants Who Underwent Repeat Ablation Procedures | 3 Participants |
Secondary
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
Number of participants with bleeding complication by ISTH class and timing of onset were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (\>=) 2 grams per deciliter (g/dL), transfusion of \>= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.
Time frame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months)
Population: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major (8-30 Days) | 0 Participants |
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM (>=31 Days) | 3 Participants |
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM (0-7 Days) | 4 Participants |
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor (0-7 Days) | 17 Participants |
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major (>=31 Days) | 0 Participants |
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor (8-30 Days) | 2 Participants |
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM (8-30 Days) | 0 Participants |
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor (>=31 Days) | 7 Participants |
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major (0-7 Days) | 0 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor (>=31 Days) | 1 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major (0-7 Days) | 0 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major (8-30 Days) | 0 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Major (>=31 Days) | 0 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM (0-7 Days) | 0 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM (8-30 Days) | 0 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | CRNM (>=31 Days) | 0 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor (0-7 Days) | 1 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Minor (8-30 Days) | 0 Participants |
Secondary
Number of Participants With Serious Non-Primary AEs
Serious non-primary adverse events were defined as serious AEs (SAEs) that are not primary adverse events. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 12 months
Population: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Serious Non-Primary AEs | 42 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Serious Non-Primary AEs | 3 Participants |
Secondary
Number of Participants With Unanticipated Adverse Device Effects (UADEs)
Number of participants with UADEs was reported.
Time frame: Up to 12 months
Population: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Number of Participants With Unanticipated Adverse Device Effects (UADEs) | 0 Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Number of Participants With Unanticipated Adverse Device Effects (UADEs) | 0 Participants |
Secondary
Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure
Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure was reported.
Time frame: Up to 12 months
Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure | 64.3 Percentage of Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure | 66.7 Percentage of Participants |
Secondary
Percentage of Participants With 12-Month Single Procedure Success
Percentage of participants with 12-month single procedure success was reported. It is defined as freedom from 1) any repeat procedure for Atrial fibrillation (AF)/Atrial tachycardia (AT)/Atrial flutter (AFL) post index procedure; 2) any class I/III AAD taking during the evaluation period; 3) documented AF/AT/AFL recurrence in evaluation period.
Time frame: Up to 12 months
Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Participants With 12-Month Single Procedure Success | 55.5 Percentage of Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Participants With 12-Month Single Procedure Success | 50.0 Percentage of Participants |
Secondary
Percentage of Participants With Cumulative PAEs
A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 12 months
Population: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Participants With Cumulative PAEs | 4.3 Percentage of Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Participants With Cumulative PAEs | 6.3 Percentage of Participants |
Secondary
Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure
Percentage of participants with ipsilateral PVI (entrance block) at the end of the procedure were reported.
Time frame: End of the Procedure (up to 12 months)
Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure | 98.8 Percentage of Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure | 100 Percentage of Participants |
Secondary
Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection
Percentage of participants with ipsilateral PVI after first encirclement without Acute reconnection was reported.
Time frame: Up to 12 months
Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection | 72.0 Percentage of Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection | 85.7 Percentage of Participants |
Secondary
Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure
Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure was reported.
Time frame: Up to 12 months
Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure | 57.1 Percentage of Participants |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure | 100 Percentage of Participants |
Secondary
Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins
Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins was reported.
Time frame: Up to 12 months
Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins | 16.9 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins | 7.1 Percentage of targeted veins |
Secondary
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
Percentage of targeted veins with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV).
Time frame: Up to 12 months
Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'n' (number of targeted veins analyzed) included all evaluable numbers of targeted veins which were analyzed at specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Anterior | 4.2 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Superior | 3.5 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Ridge | 3.9 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Posterior | 7.5 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Inferior | 1.3 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Anterior | 11.6 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Superior | 5.7 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Ridge | 9.1 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Posterior | 13.3 Percentage of targeted veins |
| VISITAG SURPOINT Module STSF Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Inferior | 6.3 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Inferior | 0.0 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Anterior | 2.4 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Anterior | 4.3 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Superior | 0.0 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Posterior | 6.1 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Ridge | 0.0 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Superior | 12.5 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Posterior | 0.0 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | RPV: Ridge | 0.0 Percentage of targeted veins |
| VISITAG SURPOINT Module ST Catheter With EPU | Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | LPV: Inferior | 2.2 Percentage of targeted veins |