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Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant | Clinical Trials | Clareo Health

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

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

NCT04118530•Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 21, 2021

Primary Completion Date

June 17, 2024

Completion Date

June 17, 2024

Last Updated

October 10, 2024

Enrollment

ACTUAL participants

Conditions

Hematopoietic Stem Cell TransplantAtrial FibrillationAtrial Flutter

Interventions

HSCT Patients

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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