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Long Term Arrhythmia Risk and Cardiovascular Events in Hemtopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study (ARCHER)

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ClinicalTrials.gov Identifier: NCT04118530
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Michael Fradley, University of South Florida

Brief Summary:

The purpose of this study is to better understand the following aims:

  1. Aim 1: To evaluate the rate of recurrent AF/AFL in 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

Condition or disease Intervention/treatment
Hematopoietic Stem Cell Transplant Atrial Fibrillation Atrial Flutter Other: HSCT Patients

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Long Term Arrhythmia Risk and Cardiovascular Events in Hemtopoietic Stem Cell
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Recurrent AF/AFL episodes [ Time Frame: 1 year ]
    Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring


Secondary Outcome Measures :
  1. Incident Episodes of Interest [ Time Frame: 1 year ]
    Incident episodes of: stroke/TIA; other thromboembolic events (not stroke/TIA); Heart failure events; ischemic heart events. Overall device implantation safety.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with the diagnosis that requires them to undergo HSCT who develop incident AF/AFL in the first 30 days of transplant.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118530


Contacts
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Contact: Heather Glunk, BSN, RN, ACRP-CP 813-259-0671 hglunk@health.usf.edu
Contact: Nhi Tran, MS 813-259-0628 nntran@health.usf.edu

Sponsors and Collaborators
University of South Florida
Medtronic
Investigators
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Principal Investigator: Michael Fradley, MD University of South Florida, Department of Internal Medicine, Division of Cardiovascular Sciences

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Responsible Party: Michael Fradley, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT04118530     History of Changes
Other Study ID Numbers: Pro00041321
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Fradley, University of South Florida:
Atrial Fibrillation
Hematopoietic Stem Cell Transplant
Atrial Flutter
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes