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

Completed

• Conditions: Atrial Fibrillation; Hematopoietic Stem Cell Transplant; Atrial Flutter
• Interventions: Other: HSCT Patients

• Registration Number: NCT04118530
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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

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 Timeline

• Study First Submitted: 2019-10-05
• Study First Submitted QC: 2019-10-05
• Study First Posted: 2019-10-08
• Study Start: 2021-04-21
• Primary Completion: 2024-06-17
• Study Completion: 2024-06-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hematopoietic Stem Cell Transplant (HSCT) Patients	HSCT Patients	- Patients with incidence of AF/AFL in the first 30 days of transplant

Primary Outcome Measures

Name	Time	Method
Recurrent AF/AFL episodes	1 year	Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Abramson Cancer Center at University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States