LSI (Lesion Index) Workflow Observational Study

Completed

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03906461

Run by

Abbott Medical Devices

People needed

143

Starts

2019-05-17

Expected to finish

2021-04-27

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must provide written informed consent prior to any clinical investigation related procedure.
• Subject is at least 18 years of age.
• Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.
• Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.
• 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:
• Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason.
• Subject was offered the drug and refused to take for any reason.

You may not qualify if…

• Previous ablation or surgery in the left atria.
• Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).
• Participation in another clinical investigation that may confound the results of this study.
• Pregnant or nursing.
• 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.
• Life expectancy less than 12 months.

Where it is running

• 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 — 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

Full record on ClinicalTrials.gov

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