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

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Atrial Flutter; Atrial Fibrillation; Hematopoietic Stem Cell Transplant

Treatments: Other: HSCT Patients

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04118530

UPCC35420

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

21 participants in 1 patient group

Hematopoietic Stem Cell Transplant (HSCT) Patients

Description:

- Patients with incidence of AF/AFL in the first 30 days of transplant

Treatment:

Other: HSCT Patients