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

  • STATUS
    Recruiting
  • End date
    Apr 17, 2023
  • participants needed
    70
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 17 June 2022
stroke
heart failure
arrhythmia
fibrillation
vascular disease
atrial flutter
recurrent atrial fibrillation

Summary

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

Description

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.

Details
Condition Hematopoietic Stem Cell Transplant, Atrial Fibrillation, Atrial Flutter
Treatment HSCT Patients
Clinical Study IdentifierNCT04118530
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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
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