Paroxysmal Atrial Fibrillation
Conditions
Brief summary
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
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.
Interventions
DEVICERadiofrequency 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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must provide written informed consent prior to any clinical investigation related procedure. 2. Subject is at least 18 years of age. 3. Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule. 4. Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation. 5. 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: 1. Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason. 2. Subject was offered the drug and refused to take for any reason.
Exclusion criteria
1. Previous ablation or surgery in the left atria. 2. Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable). 3. Participation in another clinical investigation that may confound the results of this study. 4. Pregnant or nursing. 5. 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. 6. Life expectancy less than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Achieved Lesion Index (LSI) Values | At time of procedure | The primary endpoint is a summary of Lesion Index (LSI) values achieved for radiofrequency ablation catheter lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). LSI is a proprietary index that combines contact force, radiofrequency duration, and radiofrequency current into a single value to express the gradual growth of lesion formation with increasing LSI values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ensite AutoMark Settings and Characteristics: Average RF Power Delivered | At time of procedure | Descriptive summary of EnSite AutoMark module software settings and characteristics, including average radiofrequency (RF) power delivered for each lesion |
| Ensite AutoMark Settings and Characteristics: Contact Force | At time of procedure | Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion |
| Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter | At time of procedure | Descriptive summary of EnSite AutoMark module software settings and characteristics, including AutoMark Lesion Spacing parameter for each lesion |
| Number of Participants With Acute Electrical Isolation of Pulmonary Veins | 20 minutes after last RF ablation in PV region | Acute electrical isolation of the pulmonary veins (PVs), 20 minutes after the last RF ablation in the PV region. The number of participants with acute electric isolation of all pulmonary veins is reported. |
| Number of Participants With 7-Day Device or Procedure Related SAEs | within 7-days of index procedure | Device- or procedure-related SAEs within 7-days of the index procedure |
| Number of Participants With 12-Month Device or Procedure Related SAEs | between 7 days and 12-months of index procedure | Device- or procedure-related SAEs within 12-months of index procedure |
| Number of Participants With Freedom From AF/AFL/AT Recurrence | No documented episodes greater than 30 seconds with a 24hour-Holter | Freedom from documented AF/AFL/AT recurrence at 12-months post index ablation, excluding a 90-day blanking period. Freedom from AF/AFL/AT recurrence is defined as no documented episodes greater than 30 seconds with a 24-hour Holter. |
| Number of Participants With Repeat Ablation | 12-months post index procedure (excluding 90-day blanking period) | Participants with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period) |
| Number of Participants That Required Touch up Ablation in Each Region | At time of procedure | Participants with regions that required touch up ablation. |
| Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters | At time of procedure | Descriptive summary of EnSite AutoMark module software settings and characteristics, including time and AutoMark Time parameters for each lesion. Away time refers to the maximum amount of time the catheter can remain away from the AutoMark region before a new AutoMark will be placed. The AutoMark minimum lesion time refers to the minimum amount of time the catheter tip must remain within the AutoMark region before an AutoMark lesion is placed. |
| Number of Participants That Required Index Procedure Touch-up Ablations | At time of procedure | Participants who required at least one touch-up ablation during the index procedure |
| LSI Achieved Values for Repeat RF Ablations | 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 | In participants 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 |
| Overall Procedure Time | At time of procedure | Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations |
| Overall RF Ablation Time | At time of procedure | Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, and any touch-up ablations |
| Overall Fluoroscopy Time | At time of procedure | Overall fluoroscopy time |
| Quality of Life Changes 6-Month | 6 months post index ablation, compared to baseline scores | Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 6-months post index ablation, compared to baseline scores. AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition. EQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement. |
| Quality of Life Changes 12-Month | 12-months post index ablation, compared to baseline scores | Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 12-months post index ablation, compared to baseline scores. AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition. EQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement. |
| Number of Participants on Antiarrhythmic Drugs | 12-months | Antiarrhythmic drug use at 12-months |
| Number of Participants With Health Care Utilization | collected throughout the 12-month follow-up period | 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 |
| Number of Participants in Which Pulmonary Veins Required Touch-up Ablation | At time of procedure | Participants that required touch-up ablation of each pulmonary vein (PV). |
Countries
Germany, Italy, Japan, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TactiCath SE and LSI Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.
US only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark | 143 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Completed 12-month Follow-up | Missed Visit | 6 |
| Completed 12-month Follow-up | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | TactiCath SE and LSI |
|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 44 Participants |
| History of other arrhythmia | 40 Participants |
| Hypertension | 83 Participants |
| Pacemaker or implantable cardiac monitor | 2 Participants |
| Procedure to occlude or close left atrial appendage | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 91 Participants |
| Region of Enrollment Germany | 13 participants |
| Region of Enrollment Italy | 22 participants |
| Region of Enrollment Japan | 30 participants |
| Region of Enrollment Spain | 22 participants |
| Region of Enrollment United States | 56 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 143 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 1 / 143 |
Outcome results
Primary
Mean Achieved Lesion Index (LSI) Values
The primary endpoint is a summary of Lesion Index (LSI) values achieved for radiofrequency ablation catheter lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). LSI is a proprietary index that combines contact force, radiofrequency duration, and radiofrequency current into a single value to express the gradual growth of lesion formation with increasing LSI values.
Time frame: At time of procedure
Population: LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TactiCath SE and LSI | Mean Achieved Lesion Index (LSI) Values | LSI of Lesions in Anterior Portion of Left Superior Pulmonary Vein | 4.9 Lesion Index | Standard Deviation 1 |
| TactiCath SE and LSI | Mean Achieved Lesion Index (LSI) Values | LSI of Lesions in Posterior Portion of Left Superior Pulmonary Vein | 4.8 Lesion Index | Standard Deviation 1 |
| TactiCath SE and LSI | Mean Achieved Lesion Index (LSI) Values | LSI of Lesions in Anterior Portion or Left Inferior Pulmonary Vein | 4.9 Lesion Index | Standard Deviation 1 |
| TactiCath SE and LSI | Mean Achieved Lesion Index (LSI) Values | LSI of Lesions in Posterior Portion of Left Inferior Pulmonary Vein | 4.7 Lesion Index | Standard Deviation 1 |
| TactiCath SE and LSI | Mean Achieved Lesion Index (LSI) Values | LSI of Lesions in Anterior Portion of Right Superior Pulmonary Vein | 5.1 Lesion Index | Standard Deviation 1 |
| TactiCath SE and LSI | Mean Achieved Lesion Index (LSI) Values | LSI of Lesions in Posterior Portion of Right Superior Pulmonary Vein | 5.0 Lesion Index | Standard Deviation 1 |
| TactiCath SE and LSI | Mean Achieved Lesion Index (LSI) Values | LSI of Lesions in Anterior Portion of Right Inferior Pulmonary Vein | 4.9 Lesion Index | Standard Deviation 1.1 |
| TactiCath SE and LSI | Mean Achieved Lesion Index (LSI) Values | LSI of Lesions in Posterior Portion of Right Inferior Pulmonary Veins | 5.1 Lesion Index | Standard Deviation 1 |
Secondary
Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter
Descriptive summary of EnSite AutoMark module software settings and characteristics, including AutoMark Lesion Spacing parameter for each lesion
Time frame: At time of procedure
Population: LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site. The AutoMark settings and characteristics of all lesions in the subjects with LSI data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TactiCath SE and LSI | Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter | 5.7 mm | Standard Deviation 1.7 |
Secondary
Ensite AutoMark Settings and Characteristics: Average RF Power Delivered
Descriptive summary of EnSite AutoMark module software settings and characteristics, including average radiofrequency (RF) power delivered for each lesion
Time frame: At time of procedure
Population: LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site. The AutoMark settings and characteristics of all lesions in the subjects with LSI data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TactiCath SE and LSI | Ensite AutoMark Settings and Characteristics: Average RF Power Delivered | 38.0 W | Standard Deviation 8.3 |
Secondary
Ensite AutoMark Settings and Characteristics: Contact Force
Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion
Time frame: At time of procedure
Population: LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site. The AutoMark settings and characteristics of all lesions in the subjects with LSI data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TactiCath SE and LSI | Ensite AutoMark Settings and Characteristics: Contact Force | 11.7 g | Standard Deviation 7.4 |
Secondary
Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters
Descriptive summary of EnSite AutoMark module software settings and characteristics, including time and AutoMark Time parameters for each lesion. Away time refers to the maximum amount of time the catheter can remain away from the AutoMark region before a new AutoMark will be placed. The AutoMark minimum lesion time refers to the minimum amount of time the catheter tip must remain within the AutoMark region before an AutoMark lesion is placed.
Time frame: At time of procedure
Population: LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site. The AutoMark settings and characteristics of all lesions in the subjects with LSI data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TactiCath SE and LSI | Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters | Duration | 14.4 s | Standard Deviation 9.3 |
| TactiCath SE and LSI | Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters | AutoMark Away Time Parameter | 7.1 s | Standard Deviation 2.2 |
| TactiCath SE and LSI | Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters | AutoMark Min Lesion Time Parameter | 3.2 s | Standard Deviation 0.9 |
Secondary
LSI Achieved Values for Repeat RF Ablations
In participants 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
Time frame: 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
Population: The analysis population would include only those subjects with repeat RF ablation procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | LSI Achieved Values for Repeat RF Ablations | NA Participants |
Secondary
Number of Participants in Which Pulmonary Veins Required Touch-up Ablation
Participants that required touch-up ablation of each pulmonary vein (PV).
Time frame: At time of procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TactiCath SE and LSI | Number of Participants in Which Pulmonary Veins Required Touch-up Ablation | Left Superior Vein | 11 Participants |
| TactiCath SE and LSI | Number of Participants in Which Pulmonary Veins Required Touch-up Ablation | Left Inferior Vein | 7 Participants |
| TactiCath SE and LSI | Number of Participants in Which Pulmonary Veins Required Touch-up Ablation | Right Superior Vein | 9 Participants |
| TactiCath SE and LSI | Number of Participants in Which Pulmonary Veins Required Touch-up Ablation | Right Inferior Vein | 6 Participants |
Secondary
Number of Participants on Antiarrhythmic Drugs
Antiarrhythmic drug use at 12-months
Time frame: 12-months
Population: Analysis includes subjects that completed the 12-month visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | Number of Participants on Antiarrhythmic Drugs | 52 Participants |
Secondary
Number of Participants That Required Index Procedure Touch-up Ablations
Participants who required at least one touch-up ablation during the index procedure
Time frame: At time of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | Number of Participants That Required Index Procedure Touch-up Ablations | 34 Participants |
Secondary
Number of Participants That Required Touch up Ablation in Each Region
Participants with regions that required touch up ablation.
Time frame: At time of procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TactiCath SE and LSI | Number of Participants That Required Touch up Ablation in Each Region | Anterior Portion of Left Superior Vein | 5 Participants |
| TactiCath SE and LSI | Number of Participants That Required Touch up Ablation in Each Region | Posterior Portion of left Superior Vein | 7 Participants |
| TactiCath SE and LSI | Number of Participants That Required Touch up Ablation in Each Region | Posterior Portion of Left Inferior Vein | 5 Participants |
| TactiCath SE and LSI | Number of Participants That Required Touch up Ablation in Each Region | Anterior Portion of Left Inferior Vein | 5 Participants |
| TactiCath SE and LSI | Number of Participants That Required Touch up Ablation in Each Region | Posterior Portion of Right Superior Vein | 3 Participants |
| TactiCath SE and LSI | Number of Participants That Required Touch up Ablation in Each Region | Anterior Portion of Right Superior Vein | 7 Participants |
| TactiCath SE and LSI | Number of Participants That Required Touch up Ablation in Each Region | Anterior Portion of Right Inferior Vein | 3 Participants |
| TactiCath SE and LSI | Number of Participants That Required Touch up Ablation in Each Region | Posterior Portion of Right Inferior Vein | 3 Participants |
Secondary
Number of Participants With 12-Month Device or Procedure Related SAEs
Device- or procedure-related SAEs within 12-months of index procedure
Time frame: between 7 days and 12-months of index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | Number of Participants With 12-Month Device or Procedure Related SAEs | 1 Participants |
Secondary
Number of Participants With 7-Day Device or Procedure Related SAEs
Device- or procedure-related SAEs within 7-days of the index procedure
Time frame: within 7-days of index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | Number of Participants With 7-Day Device or Procedure Related SAEs | 1 Participants |
Secondary
Number of Participants With Acute Electrical Isolation of Pulmonary Veins
Acute electrical isolation of the pulmonary veins (PVs), 20 minutes after the last RF ablation in the PV region. The number of participants with acute electric isolation of all pulmonary veins is reported.
Time frame: 20 minutes after last RF ablation in PV region
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | Number of Participants With Acute Electrical Isolation of Pulmonary Veins | 143 Participants |
Secondary
Number of Participants With 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. Freedom from AF/AFL/AT recurrence is defined as no documented episodes greater than 30 seconds with a 24-hour Holter.
Time frame: No documented episodes greater than 30 seconds with a 24hour-Holter
Population: Analysis population includes subjects with 12 Month visit complete and 24-hour Holter data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | Number of Participants With Freedom From AF/AFL/AT Recurrence | 112 Participants |
Secondary
Number of Participants With 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
Time frame: collected throughout the 12-month follow-up period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | Number of Participants With Health Care Utilization | 13 Participants |
Secondary
Number of Participants With Repeat Ablation
Participants with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period)
Time frame: 12-months post index procedure (excluding 90-day blanking period)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE and LSI | Number of Participants With Repeat Ablation | 3 Participants |
Secondary
Overall Fluoroscopy Time
Overall fluoroscopy time
Time frame: At time of procedure
Population: Analysis includes subjects in which fluoroscopy was used during the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TactiCath SE and LSI | Overall Fluoroscopy Time | 23.7 minutes | Standard Deviation 20 |
Secondary
Overall Procedure Time
Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations
Time frame: At time of procedure
Population: Analysis population includes all subjects for total initial PV isolation time and total procedure time. Total time for touch-up includes those subjects in which touch-up time was reported. Total non-PV ablation time includes those subjects in which non-PV ablation was done and time was reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TactiCath SE and LSI | Overall Procedure Time | Total initial PV isolation time | 55.6 minutes | Standard Deviation 31.2 |
| TactiCath SE and LSI | Overall Procedure Time | Total time for touch-up | 7.4 minutes | Standard Deviation 7.8 |
| TactiCath SE and LSI | Overall Procedure Time | Total non-PV ablation time | 22.5 minutes | Standard Deviation 34.7 |
| TactiCath SE and LSI | Overall Procedure Time | Total procedure time | 142.5 minutes | Standard Deviation 53.1 |
Secondary
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
Time frame: At time of procedure
Population: Analysis population included all subjects in which RF energy was delivered. Total touch-up RF time only includes subjects in which touch-up ablation was done during the index procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TactiCath SE and LSI | Overall RF Ablation Time | Total RF time for initial PVI | 19.3 minutes | Standard Deviation 9 |
| TactiCath SE and LSI | Overall RF Ablation Time | Total touch-up RF time | 2.6 minutes | Standard Deviation 3.3 |
| TactiCath SE and LSI | Overall RF Ablation Time | Total RF time for entire procedure | 22.1 minutes | Standard Deviation 10.3 |
Secondary
Quality of Life Changes 12-Month
Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 12-months post index ablation, compared to baseline scores. AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition. EQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.
Time frame: 12-months post index ablation, compared to baseline scores
Population: Analysis population includes subjects with Quality of Life scores at both baseline and 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TactiCath SE and LSI | Quality of Life Changes 12-Month | Change in overall AFEQT score from baseline to 12 months | 23.8 score on a scale | Standard Deviation 20.3 |
| TactiCath SE and LSI | Quality of Life Changes 12-Month | Change in EQ-5D-5L EQ VAS from Baseline to 12 months | 7.6 score on a scale | Standard Deviation 14.2 |
Secondary
Quality of Life Changes 6-Month
Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 6-months post index ablation, compared to baseline scores. AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition. EQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.
Time frame: 6 months post index ablation, compared to baseline scores
Population: Analysis population includes those subjects with quality of life scores assessed at both baseline and 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TactiCath SE and LSI | Quality of Life Changes 6-Month | Change in overall AFEQT Baseline to 6 months | 20.8 score on a scale | Standard Deviation 21.9 |
| TactiCath SE and LSI | Quality of Life Changes 6-Month | Change in EQ-5D-5L EQ VAS Baseline to 6 months | 6.3 score on a scale | Standard Deviation 15.3 |