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

NCT04118530 | Completed

• 1 other identifier: UPCC35420
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 3.Aim 3: To evaluate overall implantation safety in this population

Conditions

Hematopoietic Stem Cell Transplant; Atrial Fibrillation; Atrial Flutter

Keywords

Atrial Fibrillation; Hematopoietic Stem Cell Transplant; Atrial Flutter

Outcome Measures

Primary Outcomes (1)

• Recurrent AF/AFL episodes

  Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring

  1 year

Secondary Outcomes (1)

• Incident Episodes of Interest

  1 year

Study Arms (1)

Hematopoietic Stem Cell Transplant (HSCT) Patients

\- Patients with incidence of AF/AFL in the first 30 days of transplant

Other: HSCT Patients

Interventions

HSCT Patients OTHER

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

Hematopoietic Stem Cell Transplant (HSCT) Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Medtronic: collaborator

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Fradley, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2019
• First Posted: October 8, 2019
• Study Start: April 21, 2021
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)