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Trial record 6 of 12 for:    ARCHER
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Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant (ARCHER)

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ClinicalTrials.gov Identifier: NCT04118530
Recruitment Status : Active, not recruiting
First Posted : October 8, 2019
Last Update Posted : July 27, 2023
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Abramson Cancer Center at Penn Medicine

Study Description
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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

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

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.
Study Design
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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 Hematopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

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Groups and Cohorts
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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


Outcome Measures
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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.


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center at Penn Medicine
Medtronic
Investigators
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Principal Investigator: Michael Fradley, MD University of Pennsylvania
More Information
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Responsible Party: Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov Identifier: NCT04118530    
Other Study ID Numbers: UPCC35420
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
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: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abramson Cancer Center at Penn Medicine:
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