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NCT04818645 · ClinicalTrials.gov registry record · NA
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients
A NA study of Heart Failure and Atrial Fibrillation, sponsored by University of Rochester.
- Active
- Registry status
- NA
- Development phase
- 477
- Enrollment target
- 1
- Study location
NCT04818645: Active NA study of Heart Failure and Atrial Fibrillation, sponsored by University of Rochester.
NCT04818645 is a NA study of Heart Failure and Atrial Fibrillation that is active but no longer recruiting, run by University of Rochester. The registered enrollment target is 477 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04818645, a NA study of Heart Failure and Atrial Fibrillation, is active but no longer recruiting, sponsored by University of Rochester.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 477 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF). However, currently there are limited modalities for early AF detection and subsequent stroke prevention in this high-risk population. An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long term arrhythmia information via remote monitoring. The ASSERT-AF study seeks to accurately define the burden of AF and other arrhythmias in high-risk HF patients using an ASSERT ICM.
Primary Outcome
Defined as ICM detected AF in the intervention (implantable cardiac monitor) arm or captured by clinical symptoms and documented by ECG or Holter in the conventional arm.
Conditions Studied
Interventions
- DEVICE ASSERT Insertable Cardiac Monitor
- OTHER Conventional Management and monitoring
Study Locations (1)
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2028-07-01 |
| Phase | NA |
What the registry record for NCT04818645 still lists
NCT04818645 is an interventional study that assigns participants to a tested intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which ASSERT Insertable Cardiac Monitor is the first listed.
NCT04818645 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04818645 about?
NCT04818645 is a clinical study titled "Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients". Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF). However, currently there are limited modalities for early AF detection and subsequent stroke prevention in this high-risk population. An i...
What is the current status of trial NCT04818645?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 477 participants. The study started on 2023-01-31. Estimated completion is 2028-07-01.
What conditions does trial NCT04818645 study?
This clinical trial studies the following conditions: Heart Failure, Atrial Fibrillation.
What interventions are being tested in trial NCT04818645?
The interventions under investigation include: ASSERT Insertable Cardiac Monitor (DEVICE), Conventional Management and monitoring (OTHER).
Who is sponsoring clinical trial NCT04818645?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04818645 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
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 NCT04818645's enrollment target sits among peer trials
477 108th of 397 higher than 290 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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