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Completed

NCT Number: NCT03906461

LSI (Lesion Index) Workflow Observational Study

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Johannes Hospital, Dortmund, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason.
  • Subject was offered the drug and refused to take for any reason.

Exclusion criteria

  • Previous ablation or surgery in the left atria.
  • Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).
  • Participation in another clinical investigation that may confound the results of this study.
  • Pregnant or nursing.
  • 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.
  • Life expectancy less than 12 months.

Treatment and study plan

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.

Primary outcomes

  1. Mean Achieved Lesion Index (LSI) Values

    Time frame: 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 outcomes

  1. Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters

    Time frame: 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.

  2. Ensite AutoMark Settings and Characteristics: Average RF Power Delivered

    Time frame: At time of procedure

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

  3. Ensite AutoMark Settings and Characteristics: Contact Force

    Time frame: At time of procedure

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

  4. Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter

    Time frame: At time of procedure

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

  5. Number of Participants With Acute Electrical Isolation of Pulmonary Veins

    Time frame: 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.

  6. Number of Participants With 7-Day Device or Procedure Related SAEs

    Time frame: within 7-days of index procedure

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

  7. Number of Participants With 12-Month Device or Procedure Related SAEs

    Time frame: between 7 days and 12-months of index procedure

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

  8. Number of Participants With Freedom From AF/AFL/AT Recurrence

    Time frame: 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.

  9. Number of Participants With Repeat Ablation

    Time frame: 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)

  10. Number of Participants That Required Touch up Ablation in Each Region

    Time frame: At time of procedure

    Participants with regions that required touch up ablation.

  11. Number of Participants in Which Pulmonary Veins Required Touch-up Ablation

    Time frame: At time of procedure

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

  12. Number of Participants That Required Index Procedure Touch-up Ablations

    Time frame: At time of procedure

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

  13. LSI Achieved Values for Repeat RF Ablations

    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

    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

  14. Overall Procedure Time

    Time frame: 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

  15. Overall RF Ablation Time

    Time frame: 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

  16. Overall Fluoroscopy Time

    Time frame: At time of procedure

    Overall fluoroscopy time

  17. Quality of Life Changes 6-Month

    Time frame: 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.

  18. Quality of Life Changes 12-Month

    Time frame: 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.

  19. Number of Participants on Antiarrhythmic Drugs

    Time frame: 12-months

    Antiarrhythmic drug use at 12-months

  20. Number of Participants With Health Care Utilization

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

LSI (Lesion Index) Workflow Post-Market Observational Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2019
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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