Hematopoietic Stem Cell TransplantARCHERNCT04118530
Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant
An observational study of Hematopoietic Stem Cell Transplant and Atrial Fibrillation, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplant, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- HSCT Patients
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2021to 17 Jun 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Current use of a class IC or III antiarrhythmic medication
- Inability to provide informed consent/significant cognitive impairment
- Expected survival less than one year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study
The purpose of this study is to better understand the following aims:
- 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
- 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
- Aim 3: To evaluate overall implantation safety in this population
Read the 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.
- Being tested
- HSCT Patients
- Keywords
- Atrial Fibrillation, Hematopoietic Stem Cell Transplant, Atrial Flutter
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSCT PatientsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Hematopoietic Stem Cell Transplant (HSCT) Patients | - Patients with incidence of AF/AFL in the first 30 days of transplant Receives: Other: HSCT Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent AF/AFL episodes
Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start21 Apr 2021
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Michael Fradley, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118530
- Sponsor's protocol ID
- UPCC35420
- Acronym
- ARCHER
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2019
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study
- ClinicalTrials.gov ID
- NCT04118530
- Acronym / sponsor ID
- ARCHER / UPCC35420
- Keywords
- Atrial Fibrillation, Hematopoietic Stem Cell Transplant, Atrial Flutter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand the following aims:
- 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
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematopoietic Stem Cell Transplant (HSCT) Patients | – | Other: HSCT Patients- Patients with incidence of AF/AFL in the first 30 days of transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSCT PatientsProspective, 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 | Other | Hematopoietic Stem Cell Transplant (HSCT) Patients |
Primary outcome
Recurrent AF/AFL episodes
Time frame: 1 year
Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring
1 secondary outcome
Incident Episodes of Interest
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fradley, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplant and Atrial Fibrillation, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent AF/AFL episodes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.