Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study of Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint is a summary of Lesion Index (LSI) values achieved for radiofrequency ablation catheter lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). LSI is a proprietary index that combines contact force, radiofrequency duration, and radiofrequency current into a single value to express the gradual growth of lesion formation with increasing LSI values.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2019-05-17 |
| Est. Completion | 2021-04-27 |
What the finished NCT03906461 record still lists
NCT03906461 is an observational study that tracks outcomes without assigning an intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 853-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (83% lower).
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 lists 9 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Paroxysmal Atrial Fibrillation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03906461's enrollment target sits among peer trials
143 18th of 24 higher than 7 of 24 other Paroxysmal Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
RECRUITING · NA
-
Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)
RECRUITING
-
STOP AF First Post-Approval Study
RECRUITING
-
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.
RECRUITING
-
EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation
RECRUITING
-
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01861106 · 144 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations
- NCT03482245 · 144 participants · NA
The Role of Circadian Clock Proteins in Innate and Adaptive Immunity
- NCT03504683 · 144 participants · NA
MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
- NCT03905603 · 144 participants · Early Phase 1
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI