LSI (Lesion Index) Workflow Observational Study

February 21, 2024 updated by: Abbott Medical Devices

LSI (Lesion Index) Workflow Post-Market 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dortmund, Germany, 44137
        • St. Johannes Hospital
  • Italy
      • Feltre, Italy, 32032
        • Ospedale Santa Maria del Prato
  • Japan
    • Tokyo
      • Bunkyō-Ku, Tokyo, Japan, 113-8510
        • Tokyo Medical and Dental University Hospital of Medicine
      • Katsushikachō, Tokyo, Japan, 125-8506
        • The Jikei University Katsushika Medical Center
  • Spain
      • Boadilla del Monte, Spain
        • Hospital Universitario de Monteprincipe
  • United States
    • California
      • Burlingame, California, United States, 94010
        • Mills-Peninsula Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At time of procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At time of procedure
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
At time of procedure
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
At time of procedure
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
At time of procedure
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.
20 minutes after last RF ablation in PV region
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
within 7-days of index procedure
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
between 7 days and 12-months of index procedure
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.
No documented episodes greater than 30 seconds with a 24hour-Holter
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)
12-months post index procedure (excluding 90-day blanking period)
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.
At time of procedure
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).
At time of procedure
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
At time of 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 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
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
At time of procedure
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
At time of procedure
Overall Fluoroscopy Time
Time Frame: At time of procedure
Overall fluoroscopy time
At time of procedure
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.
6 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 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
Time Frame: 12-months
Antiarrhythmic drug use at 12-months
12-months
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
collected throughout the 12-month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kristen Ruffner, PhD, EP Program Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABT-CIP-10276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

TBD via publication plan

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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