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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 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.

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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.

Interventions

  • DEVICE ASSERT Insertable Cardiac Monitor
  • OTHER Conventional Management and monitoring

Study Locations (1)

New York

  • University of Rochester Medical Center - Rochester

Trial Details

FieldValue
Enrollment Target 477 participants
Start Date 2023-01-31
Est. Completion 2028-07-01
Phase NA

Sponsor

University of Rochester

636 total trials

What the Registry Record Tells You About NCT04818645

The ClinicalTrials.gov registry entry for NCT04818645 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 477 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (77% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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