LSI (Lesion Index) Workflow Observational Study

Completed

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT03906461
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-08
• Study Start: 2019-05-17
• Primary Completion: 2021-04-27
• Study Completion: 2021-04-27
• Results First Submitted: 2022-05-10
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Results First Posted: 2024-08-02
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Achieved Lesion Index (LSI) Values	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 Outcome Measures

Name	Time	Method
Ensite AutoMark Settings and Characteristics: Average RF Power Delivered	At time of procedure	Descriptive summary of EnSite AutoMark module software settings and characteristics, including average radiofrequency (RF) power delivered for each lesion
Ensite AutoMark Settings and Characteristics: Contact Force	At time of procedure	Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion
Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters	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.
Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter	At time of procedure	Descriptive summary of EnSite AutoMark module software settings and characteristics, including AutoMark Lesion Spacing parameter for each lesion
Number of Participants With Acute Electrical Isolation of Pulmonary Veins	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.
Number of Participants With 7-Day Device or Procedure Related SAEs	within 7-days of index procedure	Device- or procedure-related SAEs within 7-days of the index procedure
Number of Participants With Freedom From AF/AFL/AT Recurrence	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.
Number of Participants That Required Touch up Ablation in Each Region	At time of procedure	Participants with regions that required touch up ablation.
Number of Participants With 12-Month Device or Procedure Related SAEs	between 7 days and 12-months of index procedure	Device- or procedure-related SAEs within 12-months of index procedure
Quality of Life Changes 12-Month	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.
Number of Participants With Repeat Ablation	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)
Overall Procedure Time	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 Fluoroscopy Time	At time of procedure	Overall fluoroscopy time
Quality of Life Changes 6-Month	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.
Number of Participants in Which Pulmonary Veins Required Touch-up Ablation	At time of procedure	Participants that required touch-up ablation of each pulmonary vein (PV).
Number of Participants That Required Index Procedure Touch-up Ablations	At time of procedure	Participants who required at least one touch-up ablation during the index procedure
LSI Achieved Values for Repeat RF Ablations	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
Overall RF Ablation Time	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
Number of Participants on Antiarrhythmic Drugs	12-months	Antiarrhythmic drug use at 12-months
Number of Participants With Health Care Utilization	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

Trial Locations

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

St. Johannes Hospital; 🇩🇪 Dortmund, Germany

The Jikei University Katsushika Medical Center; 🇯🇵 Katsushikachō, Tokyo, Japan

Hospital Universitario de Monteprincipe; 🇪🇸 Boadilla del Monte, Spain

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

Tokyo Medical and Dental University Hospital of Medicine; 🇯🇵 Bunkyō-Ku, Tokyo, Japan

Ospedale Santa Maria del Prato; 🇮🇹 Feltre, Italy