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Agilis RF TSP Early Feasibility Study

StatusRecruiting
PhaseNot applicable
Started2026-02-16
View on ClinicalTrials.gov ↗

Amendment history

2026-05-29
Study Status, Study Design, Contacts/Locations v3
Enrollment increased: 20 → 60 participants
Study sites2→3
2026-03-10
Study Status, Contacts/Locations v2
Study sites1→2
2026-02-18
Withheld→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v1
Trial statusWithheld→Recruiting
Primary completion datenot stated→2026-06-01
Completion datenot stated→2026-08-03
Start datenot stated→2026-02-16
Lead sponsor[Redacted]→Abbott Medical Devices
Study title-28 characters
[TrialAgilis ofRF deviceTSP thatEarly isFeasibility not approved or cleared by the U.S. FDA]Study
2026-01-21
Original filing
This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and interventional cardiology (IC) procedures. This study will be conducted in an acute setting. Subjects will be followed through hospital discharge, and no follow-up visits will be required for this study.
Trial Details
NCT Number NCT07361445
Lead Sponsor Abbott Medical Devices
Conditions Cardiac Arrythmias, Left Atrial Appendage Closure
Enrollment 60 participants
Start Date 2026-02-16
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-08-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-02