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NCT03906461 · ClinicalTrials.gov registry record

LSI (Lesion Index) Workflow Observational Study

A clinical trial of Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices.

Completed
Registry status
143
Enrollment target
9
Study locations

NCT03906461 is a study of Paroxysmal Atrial Fibrillation that has completed, run by Abbott Medical Devices. The registered enrollment target is 143 participants, below the 853-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (83% lower). The trial reports 9 study locations across 6 states.

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The verdict

NCT03906461, a study of Paroxysmal Atrial Fibrillation, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
143 participants
Enrollment target
9
Study locations

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

261 total trials

What the Registry Record Tells You About NCT03906461

The ClinicalTrials.gov registry entry for NCT03906461 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 853-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (83% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.

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.

NCT03906461 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Other, Tokyo, California.

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.

What interventions are being tested in trial NCT03906461?

The interventions under investigation include: Radiofrequency Ablation (DEVICE).

Who is sponsoring clinical trial NCT03906461?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

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.

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

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