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OpenTrials
Completed

NCT Number: NCT04118530

Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant

The purpose of this study is to better understand the following aims:

1. Aim 1: To evaluate the rate of recurrent Atrial Fibrillation (AF)/Atrial Flutter (AFL) in hematopoietic stem call transplant (HCST) patients with incident AF/AFL identified during the initial 30 days of the transplant 2. Aim 2: To evaluate incident episodes of 1) stroke/TIA; 2) other thromboembolic events (not stroke/TIA); 3) Heart failure events; 4) Ischemic heart events 3. Aim 3: To evaluate overall implantation safety in this population

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Key information

Conditions

Hematopoietic Stem Cell Transplant Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

We propose a registry study in hematopoietic stem cell transplant (HSCT) patients with incident atrial fibrillation/atrial flutter (AF/AFL) during the initial 30 days of transplant who will be implanted with the Medtronic Reveal Linq Implantable Cardiac Monitor (ICM) within 90 days of HSCT. We will evaluate the rate of recurrent AF/AFL as well as incident episodes of major cardiovascular events and the safety of ICM implantation in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18
  • CHADS-VASc ≥ 2
  • Recovery of platelets to >50,000 within 90 days of incident atrial fibrillation (AF) diagnosis
  • Discharge from the incident stem cell transplant (SCT) hospitalization
  • Normal sinus rhythm at the time of consent

Exclusion criteria

  • Prior history of atrial fibrillation (AF) or atrial flutter
  • CHADS-VASc <2
  • Platelets <50,000 after 90 days post transplantation
  • Continued SCT hospitalization at 90 days
  • Inability to receive anticoagulation
  • AF or other arrhythmia at the time of consent
  • Current use of a class IC or III antiarrhythmic medication
  • Inability to provide informed consent/significant cognitive impairment
  • Expected survival less than one year.

Treatment and study plan

HSCT Patients

Other

Prospective, observational review of incidence of AF/AFL through Carelink remote monitoring and safety of implantation of device in this population of patients through review of standard of care follow up visits post HSCT implant

Primary outcomes

  1. Recurrent AF/AFL episodes

    Time frame: 1 year

    Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring

Secondary outcomes

  1. Incident Episodes of Interest

    Time frame: 1 year

    Incident episodes of: stroke/TIA; other thromboembolic events (not stroke/TIA); Heart failure events; ischemic heart events. Overall device implantation safety.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Medtronic

Registry information

Official study title

Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study

Acronym: ARCHER

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2019
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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