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LEAP 2 Chronic EFS

StatusRecruiting
PhaseNot applicable
Started2025-12-13
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 15, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 5 months later Mar 16, 2026 → Sep 2026
See other at-risk trials from Abbott Medical Devices

Amendment history

2026-07-14
Study Status, Study Description, Study Design, Contacts/Locations v3
Trial status changed: Active, Not Recruiting → Recruiting
Enrollment increased: 20 → 30 participants
Primary completion pushed: 2026-03-16 → 2026-09
Study description+10 characters
[...] cedure, pre (hospital) discharge, and follow-up at 1 month, 2 months, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion
Study sitesdetails revised at 1 of 1 site
2026-03-25
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2026-02→confirmed 2026-03-16
Study sitesdetails revised at 1 of 1 site
2025-12-30
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→2026-02
Completion datenot stated→2028-12
Start datenot stated→2025-12-13
Lead sponsor[Redacted]→Abbott Medical Devices
Study title-47 characters
[TrialLEAP of2 deviceChronic that is not approved or cleared by the U.S. FDA]EFS
2025-12-12
Original filing
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
Trial Details
NCT Number NCT07287423
Lead Sponsor Abbott Medical Devices
Conditions Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
Enrollment 30 participants
Start Date 2025-12-13
Primary Completion 2026-09 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-15