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This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-word environment.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Subject must provide written informed consent prior to any clinical investigation related procedure.
Subject is at least 18 years of age.
Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.
Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.
Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug.
For the purposes of this study, "intolerant" includes either:
Exclusion Criteria:
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This clinical investigation will enroll male and female subjects undergoing their first ablation procedure from the documented drug-refractory, paroxysmal atrial fibrillation (PAF) population. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Ruffner, PhD | EP Program Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mills-Peninsula Medical Center | Burlingame | California | 94010 | United States | ||
| St. Vincent Hospital |
TBD via publication plan
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment to Completed Procedure |
| |||||||||||||
| Completed 12-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Lesion Index | At time of procedure |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Perforation or Tamponade | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Abbott | 16517563101 | laura.zitellaverbick@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2019 | May 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| At time of procedure |
| 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 | At time of procedure |
| Ensite AutoMark Settings and Characteristics: Contact Force | Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion | At time of procedure |
| 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 | At time of procedure |
| 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. | 20 minutes after last RF ablation in PV region |
| Number of Participants With 7-Day Device or Procedure Related SAEs | Device- or procedure-related SAEs within 7-days of the index procedure | within 7-days of index procedure |
| Number of Participants With 12-Month Device or Procedure Related SAEs | Device- or procedure-related SAEs within 12-months of index procedure | between 7 days and 12-months of index procedure |
| 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. | No documented episodes greater than 30 seconds with a 24hour-Holter |
| Number of Participants With Repeat Ablation | Participants with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period) | 12-months post index procedure (excluding 90-day blanking period) |
| Number of Participants That Required Touch up Ablation in Each Region | Participants with regions that required touch up ablation. | At time of procedure |
| Number of Participants in Which Pulmonary Veins Required Touch-up Ablation | Participants that required touch-up ablation of each pulmonary vein (PV). | At time of procedure |
| Number of Participants That Required Index Procedure Touch-up Ablations | Participants who required at least one touch-up ablation during the index procedure | At time of procedure |
| 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 | up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable |
| Overall Procedure Time | Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations | At time of procedure |
| Overall RF Ablation Time | Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, and any touch-up ablations | At time of procedure |
| Overall Fluoroscopy Time | Overall fluoroscopy time | At time of procedure |
| 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. | 6 months post index ablation, compared to baseline scores |
| 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. | 12-months post index ablation, compared to baseline scores |
| Number of Participants on Antiarrhythmic Drugs | Antiarrhythmic drug use at 12-months | 12-months |
| 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 | collected throughout the 12-month follow-up period |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| St. Johannes Hospital | Dortmund | 44137 | Germany |
| Ospedale Santa Maria del Prato | Feltre | 32032 | Italy |
| Tokyo Medical and Dental University Hospital of Medicine | Bunkyō-Ku | Tokyo | 113-8510 | Japan |
| The Jikei University Katsushika Medical Center | Katsushikachō | Tokyo | 125-8506 | Japan |
| Hospital Universitario de Monteprincipe | Boadilla del Monte | Spain |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hypertension | Count of Participants | Participants |
|
| Pacemaker or implantable cardiac monitor | Count of Participants | Participants |
|
| Procedure to occlude or close left atrial appendage | Count of Participants | Participants |
|
| History of other arrhythmia | Count of Participants | Participants |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | s | At time of procedure | lesions | lesions |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | W | At time of procedure | lesions | lesions |
|
|
|
| Secondary | Ensite AutoMark Settings and Characteristics: Contact Force | Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion | 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. | Posted | Mean | Standard Deviation | g | At time of procedure | lesions | lesions |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | mm | At time of procedure | lesions | lesions |
|
|
|
| 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. | Posted | Count of Participants | Participants | 20 minutes after last RF ablation in PV region |
|
|
|
| Secondary | Number of Participants With 7-Day Device or Procedure Related SAEs | Device- or procedure-related SAEs within 7-days of the index procedure | Posted | Count of Participants | Participants | within 7-days of index procedure |
|
|
|
| Secondary | Number of Participants With 12-Month Device or Procedure Related SAEs | Device- or procedure-related SAEs within 12-months of index procedure | Posted | Count of Participants | Participants | between 7 days and 12-months of index procedure |
|
|
|
| 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. | Analysis population includes subjects with 12 Month visit complete and 24-hour Holter data available. | Posted | Count of Participants | Participants | No documented episodes greater than 30 seconds with a 24hour-Holter |
|
|
|
| Secondary | Number of Participants With Repeat Ablation | Participants with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period) | Posted | Count of Participants | Participants | 12-months post index procedure (excluding 90-day blanking period) |
|
|
|
| Secondary | Number of Participants That Required Touch up Ablation in Each Region | Participants with regions that required touch up ablation. | Posted | Count of Participants | Participants | At time of procedure |
|
|
|
| Secondary | Number of Participants in Which Pulmonary Veins Required Touch-up Ablation | Participants that required touch-up ablation of each pulmonary vein (PV). | Posted | Count of Participants | Participants | At time of procedure |
|
|
|
| Secondary | Number of Participants That Required Index Procedure Touch-up Ablations | Participants who required at least one touch-up ablation during the index procedure | Posted | Count of Participants | Participants | At time of procedure |
|
|
|
| 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 | The analysis population would include only those subjects with repeat RF ablation procedures. | Posted | Count of Participants | Participants | 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 |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | minutes | At time of procedure |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | minutes | At time of procedure |
|
|
|
| Secondary | Overall Fluoroscopy Time | Overall fluoroscopy time | Analysis includes subjects in which fluoroscopy was used during the procedure. | Posted | Mean | Standard Deviation | minutes | At time of procedure |
|
|
|
| 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. | Analysis population includes those subjects with quality of life scores assessed at both baseline and 6 months. | Posted | Mean | Standard Deviation | score on a scale | 6 months post index ablation, compared to baseline scores |
|
|
|
| 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. | Analysis population includes subjects with Quality of Life scores at both baseline and 12 months. | Posted | Mean | Standard Deviation | score on a scale | 12-months post index ablation, compared to baseline scores |
|
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|
| Secondary | Number of Participants on Antiarrhythmic Drugs | Antiarrhythmic drug use at 12-months | Analysis includes subjects that completed the 12-month visit. | Posted | Count of Participants | Participants | 12-months |
|
|
|
| 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 | Posted | Count of Participants | Participants | collected throughout the 12-month follow-up period |
|
|
|
| 1 |
| 143 |
| 1 |
| 143 |
| 0 |
| 0 |
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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Anterior Portion of Left Inferior Vein |
|
| Posterior Portion of Right Superior Vein |
|
| Anterior Portion of Right Superior Vein |
|
| Anterior Portion of Right Inferior Vein |
|
| Posterior Portion of Right Inferior Vein |
|
| Title | Measurements |
|---|
|
| Right Inferior Vein |
|
|
| Total non-PV ablation time |
|
|
| Total procedure time |
|
|
|
| Total RF time for entire procedure |
|
|