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NCT04076917 · ClinicalTrials.gov registry record
Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
A clinical trial, sponsored by Biotronik.
- Terminated
- Registry status
- 84
- Enrollment target
NCT04076917: Clinical Trial study, sponsored by Biotronik.
NCT04076917 is a clinical trial that was terminated before completion, run by Biotronik. The registered enrollment target is 84 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04076917 was terminated before completion, sponsored by Biotronik.
- TERMINATED
- Registry status
- 84 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's subcutaneous cardiac rhythm monitor for the detection of AF prior to an ablation procedure.
Primary Outcome
The diagnostic sensitivity of the BIOMONITOR will be determined by comparing AF events detected by the BIOMONITOR and 48 hr Holter monitor for each subject. Diagnostic sensitivity is the ability of the BIOMONITOR to correctly identify subjects who have true AF as determined by the Holter monitor. It is calculated as the number of participants with a true BIOMONITOR AF detection divided by the sum of the number of participants with a true BIOMONITOR AF detection and the number of participants wit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2021-02-24 |
Why NCT04076917 stopped before completion
NCT04076917 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 84 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04076917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04076917 about?
NCT04076917 is a clinical study titled "Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection". The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's subcutaneous cardiac rhythm monitor for the detection of AF prior to an ablation procedure.
What is the current status of trial NCT04076917?
This trial is currently terminated. The enrollment target is 84 participants. The study started on 2019-09-25. Estimated completion is 2021-02-24.
Who is sponsoring clinical trial NCT04076917?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
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