LSI (Lesion Index) Workflow Observational Study

Abbott Medical Devices143 enrolled

Overview

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: * 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

Enrollment

143

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Radiofrequency AblationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Mills-Peninsula Medical Center

Burlingame, California, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Maimonides Medical Center

Outcomes

Primary Outcomes

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.

Time frame: At time of procedure

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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Brooklyn, New York, United States

St. Johannes Hospital

Dortmund, Germany

Ospedale Santa Maria del Prato

Feltre, Italy

Tokyo Medical and Dental University Hospital of Medicine

Bunkyō-Ku, Tokyo, Japan

The Jikei University Katsushika Medical Center

Katsushikachō, Tokyo, Japan

Hospital Universitario de Monteprincipe

Boadilla del Monte, Spain

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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).

Time frame: 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

Time frame: 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

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

Overall Procedure Time

Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations

Time frame: 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

Time frame: At time of procedure

Overall Fluoroscopy Time

Overall fluoroscopy time

Time frame: 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.

Time frame: 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.

Time frame: 12-months post index ablation, compared to baseline scores

Number of Participants on Antiarrhythmic Drugs

Antiarrhythmic drug use at 12-months

Time frame: 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

Time frame: collected throughout the 12-month follow-up period