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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04235491
The ClinicalTrials.gov registry entry for NCT04235491 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 37,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,137-participant average among 29 other Bradycardia trials with a reported enrollment target (1079% higher). The listed sponsor is Medtronic, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bradycardia appearing as the primary indexed condition, and to 0 interventions.
NCT04235491 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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