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NCT04235491 · ClinicalTrials.gov registry record
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
A clinical trial of Bradycardia, sponsored by Medtronic.
- Active
- Registry status
- 37,000
- Enrollment target
- 1
- Study location
NCT04235491: Active study of Bradycardia, sponsored by Medtronic.
NCT04235491 is a study of Bradycardia that is active but no longer recruiting, run by Medtronic. The registered enrollment target is 37,000 participants, above the 3,137-participant average among 29 other Bradycardia trials with a reported enrollment target (1079% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04235491, a study of Bradycardia, is active but no longer recruiting, sponsored by Medtronic.
- ACTIVE NOT RECRUITING
- Registry status
- 37,000 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.
Primary Outcome
Micra AV leadless pacemaker system and/or procedure related complications at 30 days. Acute complications include embolism/thrombosis, event at the puncture site, cardiac effusion/perforation, device-related complication, or other complications following the implantation of a Micra AV leadless pacemaker system. Subjects' administrative claims data will be reviewed to determine the occurrence of an acute complication.
Conditions Studied
Study Locations (1)
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37,000 participants |
| Start Date | 2020-02-06 |
| Est. Completion | 2029-06 |
What the registry record for NCT04235491 still lists
NCT04235491 is an observational study that tracks outcomes without assigning an intervention. Its 37,000 participants enrollment target places it among the larger protocols in the corpus, above the 3,137-participant average among 29 other Bradycardia trials with a reported enrollment target (1079% higher).
The record links to 1 condition, with Bradycardia appearing as the primary indexed condition, and to 0 interventions.
NCT04235491 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04235491 about?
NCT04235491 is a clinical study titled "Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)". The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with Mic...
What is the current status of trial NCT04235491?
This trial is currently active not recruiting. The enrollment target is 37,000 participants. The study started on 2020-02-06. Estimated completion is 2029-06.
What conditions does trial NCT04235491 study?
This clinical trial studies the following conditions: Bradycardia.
Who is sponsoring clinical trial NCT04235491?
This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04235491 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bradycardia
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 NCT04235491's enrollment target sits among peer trials
37,000 1st of 29 the highest of 29 other Bradycardia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bradycardia 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
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