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NCT05336877 · ClinicalTrials.gov registry record
Aveir VR Coverage With Evidence Development Post-Approval Study
A clinical trial of Bradycardia and Arrythmia, sponsored by Abbott Medical Devices.
- Recruiting
- Registry status
- 8,744
- Enrollment target
- 1
- Study location
NCT05336877: Recruiting study of Bradycardia and Arrythmia, sponsored by Abbott Medical Devices.
NCT05336877 is a study of Bradycardia and Arrythmia that is actively recruiting participants, run by Abbott Medical Devices. The registered enrollment target is 8,744 participants, above the 4,111-participant average among 29 other Bradycardia trials with a reported enrollment target (113% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05336877, a study of Bradycardia and Arrythmia, is actively recruiting participants, sponsored by Abbott Medical Devices.
- RECRUITING
- Registry status
- 8,744 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
Primary Outcome
Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.
Conditions Studied
Interventions
- DEVICE Aveir VR Leadless Pacemaker System
- DEVICE Single-Chamber Transvenous Pacemaker
Study Locations (1)
California
- Abbott - Sylmar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,744 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2028-01-01 |
What NCT05336877 shows while recruiting
NCT05336877 is an observational study that tracks outcomes without assigning an intervention. Its 8,744 participants enrollment target places it among the larger protocols in the corpus, above the 4,111-participant average among 29 other Bradycardia trials with a reported enrollment target (113% higher).
The record links to 3 conditions, with Bradycardia appearing as the primary indexed condition, and to 2 interventions - of which Aveir VR Leadless Pacemaker System is the first listed.
NCT05336877 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05336877 about?
NCT05336877 is a clinical study titled "Aveir VR Coverage With Evidence Development Post-Approval Study". The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
What is the current status of trial NCT05336877?
This trial is currently recruiting. The enrollment target is 8,744 participants. The study started on 2022-06-21. Estimated completion is 2028-01-01.
What conditions does trial NCT05336877 study?
This clinical trial studies the following conditions: Bradycardia, Arrythmia, Cardiac Pacemaker.
What interventions are being tested in trial NCT05336877?
The interventions under investigation include: Aveir VR Leadless Pacemaker System (DEVICE), Single-Chamber Transvenous Pacemaker (DEVICE).
Who is sponsoring clinical trial NCT05336877?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05336877 being conducted?
This trial has 1 study location across California. 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 NCT05336877's enrollment target sits among peer trials
8,744 4th of 29 higher than 26 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.
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