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

Atrial Fibrillation Clinical Trial

— ARCHER  

Official title:

Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04118530
• Other study ID #: UPCC35420
• Status: Active, not recruiting
• Start date: April 21, 2021
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Hematopoietic Stem Cell Transplant

Intervention

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent AF/AFL episodes	Any recurrent episodes of AF/AFL lasting =2 minutes identified in ICM monitoring	1 year
Secondary	Incident Episodes of Interest	Incident episodes of: stroke/TIA; other thromboembolic events (not stroke/TIA); Heart failure events; ischemic heart events. Overall device implantation safety.	1 year