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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

Tracking Information
First Submitted Date March 29, 2019
First Posted Date April 8, 2019
Last Update Posted Date July 8, 2020
Actual Study Start Date May 17, 2019
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2019)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 4, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • First-pass PVI lesion [ Time Frame: At time of procedure ]
    Proportion of lesions generated during first-pass PVI that required touch-up ablation
  • Touch-up ablation of pulmonary viens [ Time Frame: At time of procedure ]
    Proportion of pulmonary veins (PVs) requiring touch-up ablation
  • 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
  • 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
  • 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
  • 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
  • Overall fluro time [ Time Frame: At time of procedure ]
    Overall fluoroscopy time
  • 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
  • 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
  • Antiarrhythmia medication [ Time Frame: 12-months ]
    AAD use at 12-months
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title LSI (Lesion Index) Workflow Observational Study
Official Title LSI (Lesion Index) Workflow Post-Market Observational Study
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Paroxysmal Atrial Fibrillation
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 7, 2020)
142
Original Estimated Enrollment
 (submitted: April 4, 2019)
150
Estimated Study Completion Date January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03906461
Other Study ID Numbers ABT-CIP-10276
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: TBD via publication plan
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Study Director: Kristen Ruffner, PhD EP Program Director
PRS Account Abbott Medical Devices
Verification Date July 2020