An observational study in Cardiac Pacemaker, Arrythmia and Bradycardia, sponsored by Abbott Medical Devices. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
Among 28 studies in Bradycardia by Abbott Medical Devices — 5 open to participants now, 8 under way, none of them phase 3. Bradycardia · Abbott Medical Devices.
Among the 28 studies in Bradycardia by Abbott Medical Devices, this one is the 3rd largest by enrollment of the 17 observational ones, is one of 4 that started in 2022, is one of 17 observational ones, and was the 18th registered.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's enrollment of 3,427 is above the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →5 of the 28 studies in Bradycardia by Abbott Medical Devices are open now, in 11 countries. Each count lists the studies.
Of the 51 Bradycardia studies recruiting now, 34 (67%) set no upper age limit and 9 (18%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2022.
Median enrollment 249 across the 11 interventional studies, 586 across the 17 observational. Of the 20 that completed or were terminated, 12 (60%) have results posted.
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
3 of the studies in Bradycardia by Abbott Medical Devices that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07877805Abbott Medical DevicesMerlin Expanded ECG NSR | 2027-01 |
| NCT07217392Abbott Medical DevicesLeft Bundle Branch Area Pacing (LBBAP) PMCF Study | 2027-04-30 |
| NCT07287423Abbott Medical DevicesLEAP 2 Chronic EFS | 2027-07 |
Among the 28 studies in Bradycardia by Abbott Medical Devices, from their registry updates:
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's enrollment of 3,427 is above the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Compared within Bradycardia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arrhythmias, Cardiac. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All patients who had an implant of the Aveir VR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis
Eligibility Criteria:
Non randomized
Device: Aveir VR Leadless Pacemaker System
This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention will be conducted in this study.
Number of Subjects Free from Acute Aveir VR System-Related Complications
Freedom from complications through 30 days post implant procedure
Time frame: 30 days
Number of Subjects Free from Chronic Aveir VR System-Related Complications
Freedom from Complications from 31 days through 10 years post implant procedure procedure
Time frame: 10 Years
Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications
Complication rate of the Aveir VR leadless pacemaker for individual acute and chronic complications
Time frame: 10 Years
Number of Subjects with End of Device Service Events
Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 10-year follow-up period which results in the leadless pacemaker being explanted or deactivated, another CIED implanted, or death. All instances of the end-of-service will be summarized by event type and time to event.
Time frame: 10 Years
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Sep 2034, 147 months after the start.
Of 35 industry-sponsored observational studies under Bradycardia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 79. This study's planned 147 months is above that.
Counting every sponsor, half of 73 studies reached it within 42 months; a quarter within 18 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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