CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 143 enrolled
Drug / intervention
Radiofrequency Ablationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03906461
NCT03906461N/ACompleted
CompareCT.gov

LSI (Lesion Index) Workflow Post-Market Observational Study

Abbott Medical Devices·observational·Posted Apr 8, 2019·Updated Aug 2, 2024

In Brief

An observational study evaluating Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. Completed, enrolled 143 participants across 9 sites in 5 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesGermany, Italy, Japan, Spain, United States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 8, 2019
Enrollment StartMay 17, 2019
Primary CompletionApr 27, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.2 years ago

Interventions

Radiofrequency Ablationdevice

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.