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COMPLETED

LSI (Lesion Index) Workflow Observational Study

NCT03906461 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DEVICE Radiofrequency Ablation

Study Locations (9)

Other

  • St. Johannes Hospital — Dortmund
  • Ospedale Santa Maria del Prato — Feltre
  • Hospital Universitario de Monteprincipe — Boadilla del Monte

Tokyo

  • Tokyo Medical and Dental University Hospital of Medicine — Bunkyō-Ku
  • The Jikei University Katsushika Medical Center — Katsushikachō

California

  • Mills-Peninsula Medical Center — Burlingame

Indiana

  • St. Vincent Hospital — Indianapolis

Mississippi

  • North Mississippi Medical Center — Tupelo

New York

  • Maimonides Medical Center — Brooklyn

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2019-05-17
Est. Completion 2021-04-27

Sponsor

Abbott Medical Devices

155 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03906461

The ClinicalTrials.gov registry entry for NCT03906461 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention — of which Radiofrequency Ablation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03906461 reports 9 study locations spanning 6 distinct geographic areas — top geographies include Other, Tokyo, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03906461 about?

NCT03906461 is a clinical study titled "LSI (Lesion Index) Workflow 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 Fibrillati...

What is the current status of trial NCT03906461?

This trial is currently completed. The enrollment target is 143 participants. The study started on 2019-05-17. Estimated completion is 2021-04-27.

What conditions does trial NCT03906461 study?

This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03906461?

The interventions under investigation include: Radiofrequency Ablation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03906461?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03906461 being conducted?

This trial has 9 study locations across California, Indiana, Mississippi, New York, Tokyo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial