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

Study Overview
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Brief Summary
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The purpose of this study is to better understand the following aims: 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 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 Aim 3: To evaluate overall implantation safety in this population

Detailed Description
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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.

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

Conditions
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Hematopoietic Stem Cell Transplant, Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
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* Other: HSCT Patients


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hematopoietic Stem Cell Transplant (HSCT) Patients<br>- Patients with incidence of AF/AFL in the first 30 days of transplant | Other: HSCT Patients<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Hematopoietic Stem Cell Transplant, Atrial Flutter