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NCT04926857 · ClinicalTrials.gov registry record
DEFINE AFib (Atrial Fibrillation)
A clinical trial, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Terminated
- Registry status
- 973
- Enrollment target
NCT04926857: Clinical Trial study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT04926857 is a clinical trial that was terminated before completion, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 973 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04926857 was terminated before completion, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- TERMINATED
- Registry status
- 973 participants
- Enrollment target
Study Summary
DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform. This study will enroll approximately 5,000 patients in the United States who have a Reveal LINQ or LINQ II ICM (or future market-released LINQ devices) and an Apple® iPhone® with iOS version 13 or higher. Interested participants will be screened through the Medtronic Discovery app and those eligible will complete an app-based informed consent. Participants will receive health-focused and quality of life surveys at variable timepoints. DEFINE AFib will measure healthcare interactions using administered surveys to identify said interactions. The Medtronic Discovery app will provide participants with a summary of their ICM data. Participants will be followed up to 5 years or to the end of their ICM service life.
Primary Outcome
Primary objective is to evaluate whether summary and episodic measurements collected by market-released LINQ ICMs are able to predict increased AF-related healthcare utilization (HCU), which are confirmed healthcare visits in the inpatient hospital, outpatient hospital, clinic/office, emergency department, or other care location (including remote visits) where AF was a reason or suspected reason for healthcare interaction. A predictive model was trained on 70% of the patients with adequate data
Interventions
- OTHER Non-Interventional
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 973 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2024-01-25 |
Why NCT04926857 stopped before completion
NCT04926857 is an observational study that tracks outcomes without assigning an intervention. The registered 973 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Non-Interventional is the first listed.
NCT04926857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04926857 about?
NCT04926857 is a clinical study titled "DEFINE AFib (Atrial Fibrillation)". DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform. This study will enroll approximately 5,000 patients in the United States who have a Reveal LINQ or LINQ II ICM (or future market-released LINQ devices) and an Ap...
What is the current status of trial NCT04926857?
This trial is currently terminated. The enrollment target is 973 participants. The study started on 2021-06-21. Estimated completion is 2024-01-25.
What interventions are being tested in trial NCT04926857?
The interventions under investigation include: Non-Interventional (OTHER).
Who is sponsoring clinical trial NCT04926857?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
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