Trial Outcomes & Findings for LSI (Lesion Index) Workflow Observational Study (NCT NCT03906461)

NCT ID: NCT03906461

Last Updated: 2024-08-02

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 143 participants
• Primary outcome timeframe: At time of procedure
• Results posted on: 2024-08-02

Participant Flow

Participant milestones

Measure	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
Enrollment to Completed Procedure STARTED	143
Enrollment to Completed Procedure COMPLETED	143
Enrollment to Completed Procedure NOT COMPLETED	0
Completed 12-month Follow-up STARTED	143
Completed 12-month Follow-up COMPLETED	133
Completed 12-month Follow-up NOT COMPLETED	10

Reasons for withdrawal

Measure	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
Completed 12-month Follow-up Withdrawal by Subject	4
Completed 12-month Follow-up Missed Visit	6

Baseline Characteristics

LSI (Lesion Index) Workflow Observational Study

Baseline characteristics by cohort

Measure	TactiCath SE and LSI n=143 Participants 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
Age, Continuous	62.2 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	44 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants
Region of Enrollment Japan	30 participants n=5 Participants
Region of Enrollment Italy	22 participants n=5 Participants
Region of Enrollment Germany	13 participants n=5 Participants
Region of Enrollment Spain	22 participants n=5 Participants
Hypertension	83 Participants n=5 Participants
Pacemaker or implantable cardiac monitor	2 Participants n=5 Participants
Procedure to occlude or close left atrial appendage	0 Participants n=5 Participants
History of other arrhythmia	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	TactiCath SE and LSI n=137 Participants 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
Mean Achieved Lesion Index (LSI) Values LSI of Lesions in Anterior Portion of Left Superior Pulmonary Vein	4.9 Lesion Index Standard Deviation 1.0
Mean Achieved Lesion Index (LSI) Values LSI of Lesions in Posterior Portion of Left Superior Pulmonary Vein	4.8 Lesion Index Standard Deviation 1.0
Mean Achieved Lesion Index (LSI) Values LSI of Lesions in Anterior Portion or Left Inferior Pulmonary Vein	4.9 Lesion Index Standard Deviation 1.0
Mean Achieved Lesion Index (LSI) Values LSI of Lesions in Posterior Portion of Left Inferior Pulmonary Vein	4.7 Lesion Index Standard Deviation 1.0
Mean Achieved Lesion Index (LSI) Values LSI of Lesions in Anterior Portion of Right Superior Pulmonary Vein	5.1 Lesion Index Standard Deviation 1.0
Mean Achieved Lesion Index (LSI) Values LSI of Lesions in Posterior Portion of Right Superior Pulmonary Vein	5.0 Lesion Index Standard Deviation 1.0
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
Mean Achieved Lesion Index (LSI) Values LSI of Lesions in Posterior Portion of Right Inferior Pulmonary Veins	5.1 Lesion Index Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TactiCath SE and LSI n=12940 lesions 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
Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters Duration	14.4 s Standard Deviation 9.3
Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters AutoMark Away Time Parameter	7.1 s Standard Deviation 2.2
Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters AutoMark Min Lesion Time Parameter	3.2 s Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Descriptive summary of EnSite AutoMark module software settings and characteristics, including average radiofrequency (RF) power delivered for each lesion

Outcome measures

Measure	TactiCath SE and LSI n=12940 lesions 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
Ensite AutoMark Settings and Characteristics: Average RF Power Delivered	38.0 W Standard Deviation 8.3

SECONDARY outcome

Timeframe: 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.

Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion

Outcome measures

Measure	TactiCath SE and LSI n=12939 lesions 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
Ensite AutoMark Settings and Characteristics: Contact Force	11.7 g Standard Deviation 7.4

SECONDARY outcome

Timeframe: 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.

Descriptive summary of EnSite AutoMark module software settings and characteristics, including AutoMark Lesion Spacing parameter for each lesion

Outcome measures

Measure	TactiCath SE and LSI n=12940 lesions 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
Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter	5.7 mm Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Number of Participants With Acute Electrical Isolation of Pulmonary Veins	143 Participants

SECONDARY outcome

Timeframe: within 7-days of index procedure

Device- or procedure-related SAEs within 7-days of the index procedure

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Number of Participants With 7-Day Device or Procedure Related SAEs	1 Participants

SECONDARY outcome

Timeframe: between 7 days and 12-months of index procedure

Device- or procedure-related SAEs within 12-months of index procedure

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Number of Participants With 12-Month Device or Procedure Related SAEs	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TactiCath SE and LSI n=117 Participants 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
Number of Participants With Freedom From AF/AFL/AT Recurrence	112 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Number of Participants With Repeat Ablation	3 Participants

SECONDARY outcome

Timeframe: At time of procedure

Participants with regions that required touch up ablation.

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Number of Participants That Required Touch up Ablation in Each Region Anterior Portion of Left Superior Vein	5 Participants
Number of Participants That Required Touch up Ablation in Each Region Posterior Portion of left Superior Vein	7 Participants
Number of Participants That Required Touch up Ablation in Each Region Posterior Portion of Left Inferior Vein	5 Participants
Number of Participants That Required Touch up Ablation in Each Region Anterior Portion of Left Inferior Vein	5 Participants
Number of Participants That Required Touch up Ablation in Each Region Posterior Portion of Right Superior Vein	3 Participants
Number of Participants That Required Touch up Ablation in Each Region Anterior Portion of Right Superior Vein	7 Participants
Number of Participants That Required Touch up Ablation in Each Region Anterior Portion of Right Inferior Vein	3 Participants
Number of Participants That Required Touch up Ablation in Each Region Posterior Portion of Right Inferior Vein	3 Participants

SECONDARY outcome

Timeframe: At time of procedure

Participants that required touch-up ablation of each pulmonary vein (PV).

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Number of Participants in Which Pulmonary Veins Required Touch-up Ablation Left Superior Vein	11 Participants
Number of Participants in Which Pulmonary Veins Required Touch-up Ablation Left Inferior Vein	7 Participants
Number of Participants in Which Pulmonary Veins Required Touch-up Ablation Right Superior Vein	9 Participants
Number of Participants in Which Pulmonary Veins Required Touch-up Ablation Right Inferior Vein	6 Participants

SECONDARY outcome

Timeframe: At time of procedure

Participants who required at least one touch-up ablation during the index procedure

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Number of Participants That Required Index Procedure Touch-up Ablations	34 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	TactiCath SE and LSI n=3 Participants 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
LSI Achieved Values for Repeat RF Ablations	NA Participants There was an insufficient number of participants with events.

SECONDARY outcome

Timeframe: 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.

Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Overall Procedure Time Total initial PV isolation time	55.6 minutes Standard Deviation 31.2
Overall Procedure Time Total time for touch-up	7.4 minutes Standard Deviation 7.8
Overall Procedure Time Total non-PV ablation time	22.5 minutes Standard Deviation 34.7
Overall Procedure Time Total procedure time	142.5 minutes Standard Deviation 53.1

SECONDARY outcome

Timeframe: 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.

Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, and any touch-up ablations

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Overall RF Ablation Time Total RF time for initial PVI	19.3 minutes Standard Deviation 9.0
Overall RF Ablation Time Total touch-up RF time	2.6 minutes Standard Deviation 3.3
Overall RF Ablation Time Total RF time for entire procedure	22.1 minutes Standard Deviation 10.3

SECONDARY outcome

Timeframe: At time of procedure

Population: Analysis includes subjects in which fluoroscopy was used during the procedure.

Overall fluoroscopy time

Outcome measures

Measure	TactiCath SE and LSI n=127 Participants 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
Overall Fluoroscopy Time	23.7 minutes Standard Deviation 20.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TactiCath SE and LSI n=140 Participants 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
Quality of Life Changes 6-Month Change in overall AFEQT Baseline to 6 months	20.8 score on a scale Standard Deviation 21.9
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TactiCath SE and LSI n=133 Participants 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
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
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 outcome

Timeframe: 12-months

Population: Analysis includes subjects that completed the 12-month visit.

Antiarrhythmic drug use at 12-months

Outcome measures

Measure	TactiCath SE and LSI n=133 Participants 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
Number of Participants on Antiarrhythmic Drugs	52 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	TactiCath SE and LSI n=143 Participants 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
Number of Participants With Health Care Utilization	13 Participants

Adverse Events

TactiCath SE and LSI

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure

TactiCath SE and LSI n=143 participants at risk 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

Cardiac disorders Cardiac Perforation or Tamponade

0.70% 1/143 • Number of events 1 • 12 months Per protocol, only device or procedure-related serious adverse events were collected and reported. While defined in the protocol, non-serious and non-related adverse event data was not collected in this study. Determination of whether there was a reasonable possibility that an investigational product or device under investigation caused or contributed to an SAE was determined by the investigator.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Scientist

Abbott

Phone: 16517563101

Email: laura.zitellaverbick@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee First publication of study results will be made as a joint multi-center publication with investigators from all sites contributing data. Institutions may publish data and results individually from its site after any of the following (1) a multi-center publication is published, (2) no multicenter publication is submitted within eighteen months after closures of the Study at all sites or (3) sponsor confirms in writing there will be no multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER