Atrial FibrillationMANAGE-AFNCT05978466
MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
An observational study of Atrial Fibrillation, run by CorVita Science Foundation at 1 site in United States.
Trial summary
The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All subjects with the diagnosis of atrial fibrillation can be enrolled into the study regardless of sex, age or medical history
Who may be able to join
- Diagnosis of valvular or non valvular atrial fibrillation
- ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D. Holter Monitor E. Implantable loop recorder
Who cannot join
- Age below 18 years.
- Clinical evidence that death within 6 months is possible
- Inability to consent to the research or sign a consent form
- Inability to follow up at the research clinic at least annually for continuity of AF care and management
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CorVita Science Foundation (NFP)
Chicago, Illinois, 60605
Edward Burke, 773-432-4888, eddie@corvitahealth.org
Martin C Burke, DO, 773-432-4888, mburke@corvitahealth.org
About this study
Official title: MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Normal care is designed to help prevent this from happening and to lessen or eliminate the symptoms patients may have. There are many different types of AF as well as numerous ways in which a variety of patients are treated. The investigators are interested in gathering more information to better keep track of patient treatment patterns (trends) that may differ from physician to physician, hospital to hospital, medication to medication, patient to patient and if necessary, procedure to procedure.
Read the detailed description
The objective of this research is to establish a contemporary and simple to construct AF management registry that expands progressively over the continuum of care for each individual patient. The registry will be used to determine the course and progression of AF management in preventing thrombo-embolic events using rhythm and rate control interventions.
Primary endpoints:
- Atrial fibrillation natural history
- Thrombo-embolic event
- Death
Secondary endpoints:
- Bleeding
- Pro-arrhythmia
- Patient adherence
- Treatment complication
- Conditions
- Atrial Fibrillation
- Keywords
- atrial arrhythmia, atrial fibrillation, stroke, bleeding, Left Atrial Appendage Occlusion
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Atrial fibrillation
The natural progression of the condition will be assessed per medical record review
Measured: From enrollment to 10- year study completion
Number of participants who had thrombo-embolic event
All strokes, transient ischemic and systemic thrombo-embolic events
Measured: From enrollment to 10- year study completion
Mortality
All cause death will be noted
Measured: From enrollment to 10- year study completion
Secondary outcomes (4)
Number of participants who have experienced bleeding
All bleeding events events will be will be assessed throughout the duration of the study per medical record review
Measured: From enrollment to 10- year study completion
Number of patients who have had pro-arrhythmia events
All pro-arrhythmic events will be documented and assessed
Measured: From enrollment to 10- year study completion
Number of patients who have had patient adherence events
Events relating to subject non-compliance of medications will be documented for the duration of the study per medical record review
Measured: From enrollment to 10- year study completion
Treatment complication
All adverse outcomes/events related to routine standard of care treatments will be noted and assessed for the duration of the study per medical record review
Measured: From enrollment to 10- year study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start22 Dec 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorVita Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin C Burke, DO, Principal investigator, Chief Scientific Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978466
- Sponsor's protocol ID
- 2017-CSF-00100
- Acronym
- MANAGE-AF
- Status last verified
- Jan 2024
- First submitted
- 11 Apr 2019
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to publish the results or outcomes associated with this registry to major peer-reviewed journals, didactic or poster sessions at national/international medical conferences.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
- ClinicalTrials.gov ID
- NCT05978466
- Acronym / sponsor ID
- MANAGE-AF / 2017-CSF-00100
- Conditions
- Atrial Fibrillation
- Keywords
- atrial arrhythmia, atrial fibrillation, stroke, bleeding, Left Atrial Appendage Occlusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- CorVita Science FoundationUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2023 (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 research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Normal care is designed to help prevent this from happening and to lessen or eliminate the symptoms patients may have. There are many different types of AF as well as numerous ways in which a variety of patients are treated. The investigators are interested in gathering more information to better keep track of patient treatment patterns (trends) that may differ from physician to physician, hospital to hospital, medication to medication, patient to patient and if necessary, procedure to procedure.
Detailed description
The objective of this research is to establish a contemporary and simple to construct AF management registry that expands progressively over the continuum of care for each individual patient. The registry will be used to determine the course and progression of AF management in preventing thrombo-embolic events using rhythm and rate control interventions.
Primary endpoints:
- Atrial fibrillation natural history
- Thrombo-embolic event
- Death
Secondary endpoints:
- Bleeding
- Pro-arrhythmia
- Patient adherence
- Treatment complication
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects with the diagnosis of atrial fibrillation can be enrolled into the study regardless of sex, age or medical history
Key inclusion criteria (2 listed)
- Diagnosis of valvular or non valvular atrial fibrillation
- ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D. Holter Monitor E. Implantable loop recorder
Key exclusion criteria (4 listed)
- Age below 18 years.
- Clinical evidence that death within 6 months is possible
- Inability to consent to the research or sign a consent form
- Inability to follow up at the research clinic at least annually for continuity of AF care and management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of Atrial fibrillation
Time frame: From enrollment to 10- year study completion
The natural progression of the condition will be assessed per medical record review
Number of participants who had thrombo-embolic event
Time frame: From enrollment to 10- year study completion
All strokes, transient ischemic and systemic thrombo-embolic events
Mortality
Time frame: From enrollment to 10- year study completion
All cause death will be noted
4 secondary outcomes
Number of participants who have experienced bleeding
Time frame: From enrollment to 10- year study completion
Number of patients who have had pro-arrhythmia events
Time frame: From enrollment to 10- year study completion
Number of patients who have had patient adherence events
Time frame: From enrollment to 10- year study completion
Treatment complication
Time frame: From enrollment to 10- year study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Research foundation's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to publish the results or outcomes associated with this registry to major peer-reviewed journals, didactic or poster sessions at national/international medical conferences.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Martin C Burke, DO principal investigator
Chief Scientific Officer
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 Atrial Fibrillation, run by CorVita Science Foundation 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward M Burke (773-432-4888, eddie@corvitahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Atrial fibrillation (time frame: From enrollment to 10- year study completion). The study lists 3 primary outcomes in all. 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 18 Jan 2024.