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LSI (Lesion Index) Workflow Observational Study

NCT03906461 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 143

Last updated 2024-08-02

Study results available
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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.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Radiofrequency Ablation

The Tacticath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) is designed to facilitate electrophysiological mapping of the heart chambers and to transmit radiofrequency (RF) current to the catheter tip electrode for intracardiac ablation purposes.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Kristen Ruffner, PhD · EP Program Director

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-17
Primary Completion
2021-04-27
Completion
2021-04-27
FDA Device
Yes

Countries

  • United States
  • Germany
  • Italy
  • Japan
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03906461 on ClinicalTrials.gov