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LSI (Lesion Index) Workflow Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03906461
Recruitment Status : Active, not recruiting
First Posted : April 8, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Device: Radiofrequency Ablation

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.

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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LSI (Lesion Index) Workflow Post-Market Observational Study
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Radiofrequency 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.


Primary Outcome Measures :
  1. Primary LSI-Achieved Value Endpoint [ Time Frame: At time of procedure ]
    The primary endpoint is a summary of LSI values achieved for RF lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs).


Secondary Outcome Measures :
  1. Ensite AutoMap and AutoMark settings [ Time Frame: At time of procedure ]
    Descriptive summary of EnSite AutoMap and AutoMark module software settings, including LSI threshold settings (in OUS), contact force, time, power, flow settings, and AutoMark spacing for each procedure

  2. Electic Isolation of Pulmonary Veins [ Time Frame: 20 minutes after last RF ablation in PV region ]
    Acute electrical isolation of PVs, 20 minutes after last RF ablation in PV region

  3. 7-Day Device or Procedure related SAE rate [ Time Frame: within 7-days of index procedure ]
    Device- or procedure-related SAEs within 7-days and 12-months of index procedure

  4. 12-Month Device or Procedure related SAE rate [ Time Frame: within 12-months of index procedure ]
    Device- or procedure-related SAEs within 7-days and 12-months of index procedure

  5. 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

  6. Repeat Ablation Proportion [ Time Frame: 12-months post index procedure (excluding 90-day blanking period) ]
    Proportion of patients with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period)

  7. First-pass PVI lesion [ Time Frame: At time of procedure ]
    Proportion of lesions generated during first-pass PVI that required touch-up ablation

  8. Touch-up ablation of pulmonary viens [ Time Frame: At time of procedure ]
    Proportion of pulmonary veins (PVs) requiring touch-up ablation

  9. Index procedure touch-up ablations [ Time Frame: At time of procedure ]
    Proportion of patients who required at least one touch-up ablation during the index procedure

  10. 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 patients 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

  11. 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

  12. 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

  13. Overall fluro time [ Time Frame: At time of procedure ]
    Overall fluoroscopy time

  14. Quality of life changes 6-Month [ Time Frame: 6 months post index ablation, compared to baseline scores ]
    Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-months post index ablation, compared to baseline scores

  15. Quality of life changes 12-Month [ Time Frame: 12-months post index ablation, compared to baseline scores ]
    Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-months post index ablation, compared to baseline scores

  16. Antiarrhythmia medication [ Time Frame: 12-months ]
    AAD use at 12-months

  17. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906461


Locations
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United States, California
Mills-Peninsula Medical Center
Burlingame, California, United States, 94010
United States, Mississippi
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Kristen Ruffner, PhD EP Program Director
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03906461    
Other Study ID Numbers: ABT-CIP-10276
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: TBD via publication plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes