RECRUITING

Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients (ASSERT-AF)

Quick Facts

Study Start:2023-01-31
Study Completion:2028-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04818645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female patients more than 18 years of age (no upper age limit)
  2. * HF exacerbation requiring initiation or augmentation of decongestive therapy in a hospital setting (hospitalization or emergency department visit) during the past 24 calendar months prior to consent date OR current treatment with loop-diuretics (furosemide, bumetanide, or torsemide).
  3. * LVEF \> 35% on a cardiac imaging study (echocardiogram, nuclear imaging, cardiac magnetic resonance imaging) performed during the past 24 calendar months prior to consent date
  4. * One or more FDA-approved indications for an Abbott ICM (unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias).
  5. * Willing to undergo an Abbott ICM implant and agree to remote ICM monitoring.
  1. * Existing implantable cardioverter defibrillator (ICD), biventricular ICD, implantable cardiac monitor or pacemaker.
  2. * Known or documented history AF or atrial flutter any time in past.
  3. * Has had a heart transplant
  4. * Participation in other clinical trials (observational registries are allowed with approval from the Coordination Center)
  5. * Unable or unwilling to cooperate with the protocol
  6. * Unable or unwilling to sign the consent for participation

Contacts and Locations

Study Contact

Ilan Goldenberg, MD
CONTACT
585-275-5391
ilan.goldenberg@heart.rochester.edu
Nicole Guerrero, MBA
CONTACT
Nicole.Guerrero@heart.rochester.edu

Principal Investigator

Ilan Goldenberg, MD
PRINCIPAL_INVESTIGATOR
University of Rochester

Study Locations (Sites)

University of Rochester Medical Center
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Ilan Goldenberg, MD, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-31
Study Completion Date2028-07-01

Study Record Updates

Study Start Date2023-01-31
Study Completion Date2028-07-01

Terms related to this study

Keywords Provided by Researchers

  • Implantable cardiac monitor
  • Atrial fibrillation
  • Heart failure
  • Remote monitoring
  • Stroke

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Heart Failure