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NCT04559945 · ClinicalTrials.gov registry record · NA
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
A NA study of Bradycardia and Cardiac Rhythm Disorder, sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 326
- Enrollment target
- 20
- Study locations
NCT04559945: Active NA study of Bradycardia and Cardiac Rhythm Disorder, sponsored by Abbott Medical Devices.
NCT04559945 is a NA study of Bradycardia and Cardiac Rhythm Disorder that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 326 participants, below the 4,401-participant average among 29 other Bradycardia trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04559945, a NA study of Bradycardia and Cardiac Rhythm Disorder, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 326 participants
- Enrollment target
- 20
- Study locations
Study Summary
prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
Primary Outcome
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported
Conditions Studied
Interventions
- DEVICE Aveir VR Leadless Pacemaker System
Study Locations (20)
California
- University of Southern California - Long Beach
- Premier Cardiology Inc - Newport Beach
- Huntington Memorial Hospital - Pasadena
Kentucky
- St. Elizabeth Medical Center - South Unit - Edgewood
- Baptist Health Lexington - Lexington
- University of Kentucky - Lexington
Alabama
- University Hospital - University of Alabama at Birmingham (UAB) - Birmingham
- The Heart Center PC - Huntsville
Florida
- Naples Heart Rhythm Specialists PA - Naples
- Orlando Health - Orlando
Georgia
- Piedmont Athens Regional Medical Center - Athens
- Redmond Regional Medical Center - Rome
Kansas
- Kansas University Medical Center - Kansas City
- Kansas City Cardiac Arrhythmia Research Foundation - Overland Park
Michigan
- Ascension St. John Hospital - Detroit
- Sparrow Clinical Research Institute - Lansing
Arizona
- Honor Health - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2023-08-31 |
| Phase | NA |
What the registry record for NCT04559945 still lists
NCT04559945 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 4,401-participant average among 29 other Bradycardia trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Bradycardia appearing as the primary indexed condition, and to 1 intervention - of which Aveir VR Leadless Pacemaker System is the first listed.
NCT04559945 names 20 study sites across 11 states, led by California, Kentucky, Alabama.
Frequently Asked Questions
What is clinical trial NCT04559945 about?
NCT04559945 is a clinical study titled "The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System". prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
What is the current status of trial NCT04559945?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 326 participants. The study started on 2020-11-13. Estimated completion is 2023-08-31.
What conditions does trial NCT04559945 study?
This clinical trial studies the following conditions: Bradycardia, Cardiac Rhythm Disorder.
What interventions are being tested in trial NCT04559945?
The interventions under investigation include: Aveir VR Leadless Pacemaker System (DEVICE).
Who is sponsoring clinical trial NCT04559945?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04559945 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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 NCT04559945's enrollment target sits among peer trials
326 20th of 29 higher than 10 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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