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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation; Atrial Flutter; Hematopoietic Stem Cell Transplant
• Intervention / Treatment: Other: HSCT Patients

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Michael Fradley, MD; Phone Number: 215-611-6799; Email: michael.fradley@pennmedicine.upenn.edu
• Study Contact Backup: Name: Amanda Smith, BA, MA; Email: amanda.smith4@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center at University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with the diagnosis that requires them to undergo HSCT who develop incident AF/AFL in the first 30 days of transplant.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hematopoietic Stem Cell Transplant (HSCT) Patients; - Patients with incidence of AF/AFL in the first 30 days of transplant	Other: HSCT Patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent AF/AFL episodes	Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident Episodes of Interest	Incident episodes of: stroke/TIA; other thromboembolic events (not stroke/TIA); Heart failure events; ischemic heart events. Overall device implantation safety.	1 year

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: Medtronic
• Investigators: Principal Investigator: Michael Fradley, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 5, 2019
• First Submitted That Met QC Criteria: October 5, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Hematopoietic Stem Cell Transplant; Atrial Flutter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: UPCC35420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No