Atrial Fibrillation, Atrial Flutter, Hematopoietic Stem Cell Transplant
Conditions
Keywords
Atrial Fibrillation, Hematopoietic Stem Cell Transplant, Atrial Flutter
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.
Interventions
OTHERHSCT 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
Sponsors
Medtronic
Abramson Cancer Center at Penn Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent AF/AFL episodes | 1 year | Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed