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

NCT ID: NCT04118530

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2024-06-17

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.

Conditions

Hematopoietic Stem Cell Transplant; Atrial Fibrillation; Atrial Flutter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hematopoietic Stem Cell Transplant (HSCT) Patients

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

HSCT Patients

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Fradley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC35420

Identifier Type: -

Identifier Source: org_study_id