Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04118530
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2019-10-05
Brief Title:
Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant Survivors Reveal Linq Cancer Registry Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCHER
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 AFAtrial Flutter AFL in hematopoietic stem call transplant HCST patients with incident AFAFL identified during the initial 30 days of the transplant
2 Aim 2 To evaluate incident episodes of 1 strokeTIA 2 other thromboembolic events not strokeTIA 3 Heart failure events 4 Ischemic heart events
3 Aim 3 To evaluate overall implantation safety in this population
1 Aim 1 To evaluate the rate of recurrent Atrial Fibrillation AFAtrial Flutter AFL in hematopoietic stem call transplant HCST patients with incident AFAFL identified during the initial 30 days of the transplant
2 Aim 2 To evaluate incident episodes of 1 strokeTIA 2 other thromboembolic events not strokeTIA 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 fibrillationatrial flutter AFAFL 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 AFAFL as well as incident episodes of major cardiovascular events and the safety of ICM implantation in this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None