Clinical trial NCT03906461: LSI (Lesion Index) Workflow Observational Study
Official title: LSI (Lesion Index) Workflow Post-Market Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Mean Achieved Lesion Index (LSI) Values
timeFrame: At time of procedure
Secondary outcomes:
measure: Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters
timeFrame: At time of procedure
measure: Ensite AutoMark Settings and Characteristics: Average RF Power Delivered
timeFrame: At time of procedure
measure: Ensite AutoMark Settings and Characteristics: Contact Force
timeFrame: At time of procedure
measure: Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter
timeFrame: At time of procedure
measure: Number of Participants With Acute Electrical Isolation of Pulmonary Veins
timeFrame: 20 minutes after last RF ablation in PV region
measure: Number of Participants With 7-Day Device or Procedure Related SAEs
timeFrame: within 7-days of index procedure
measure: Number of Participants With 12-Month Device or Procedure Related SAEs
timeFrame: between 7 days and 12-months of index procedure
measure: Number of Participants With Freedom From AF/AFL/AT Recurrence
timeFrame: No documented episodes greater than 30 seconds with a 24hour-Holter
measure: Number of Participants With Repeat Ablation
timeFrame: 12-months post index procedure (excluding 90-day blanking period)
measure: Number of Participants That Required Touch up Ablation in Each Region
timeFrame: At time of procedure
measure: Number of Participants in Which Pulmonary Veins Required Touch-up Ablation
timeFrame: At time of procedure
measure: Number of Participants That Required Index Procedure Touch-up Ablations
timeFrame: At time of procedure
measure: LSI Achieved Values for Repeat RF Ablations
timeFrame: 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
measure: Overall Procedure Time
timeFrame: At time of procedure
measure: Overall RF Ablation Time
timeFrame: At time of procedure
measure: Overall Fluoroscopy Time
timeFrame: At time of procedure
measure: Quality of Life Changes 6-Month
timeFrame: 6 months post index ablation, compared to baseline scores
measure: Quality of Life Changes 12-Month
timeFrame: 12-months post index ablation, compared to baseline scores
measure: Number of Participants on Antiarrhythmic Drugs
timeFrame: 12-months
measure: Number of Participants With Health Care Utilization
timeFrame: collected throughout the 12-month follow-up period
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Mills-Peninsula Medical Center
state: California
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Dortmund
country: Germany
facility: St. Johannes Hospital
city: Feltre
country: Italy
facility: Ospedale Santa Maria del Prato
city: Bunkyō-Ku
country: Japan
facility: Tokyo Medical and Dental University Hospital of Medicine
state: Tokyo
city: Katsushikachō
country: Japan
facility: The Jikei University Katsushika Medical Center
state: Tokyo
city: Boadilla del Monte
country: Spain
facility: Hospital Universitario de Monteprincipe
Study officials:
affiliation: EP Program Director
name: Kristen Ruffner, PhD
role: STUDY_DIRECTOR
References: