Atrial FibrillationHEISTNCT04860882
HEart Surgery In Atrial Fibrillation and Supraventicular Tachycardia
An observational study of Atrial Fibrillation, run by Nicolaus Copernicus University.
Trial summary
Atrial fibrillation is the most common cardiac arrhythmia, the incidence of which increases drastically with age. As more and more elderly patients undergo heart surgery, the proportion of patients in this population will increase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 20 Apr 2021
- 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: Patients with atrial fibrillation referred for cardiac surgery in the 5 Polish participating centers.
Who may be able to join
- Referred for heart surgery,
- preoperative atrial fibrillation
Who cannot join
- age<18 years old
About this study
Atrial fibrillation is the most common cardiac arrhythmia, the incidence of which increases drastically with age. As more and more elderly patients undergo heart surgery, the proportion of patients in this population will increase. Atrial fibrillation has been shown to be a poor prognostic factor in several surgical situations. The aim of our study was to assess long-term mortality among patients with preoperative AF under various cardiac surgery settings, with a particular emphasis on the strategy of coronary revascularization.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, heart surgery, cabg, valve surgery, preoperative, mortality, grafts
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause
Through polish national health fund we are able to determine patient status (dead or alive)
Measured: 2008-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Jan 2012
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Kowalewski, Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860882
- Sponsor's protocol ID
- HEIST
- Acronym
- HEIST
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEart Surgery In Atrial Fibrillation and Supraventicular Tachycardia
- ClinicalTrials.gov ID
- NCT04860882
- Acronym / sponsor ID
- HEIST / HEIST
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, heart surgery, cabg, valve surgery, preoperative, mortality, grafts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 27 Apr 2021 (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.
Atrial fibrillation is the most common cardiac arrhythmia, the incidence of which increases drastically with age. As more and more elderly patients undergo heart surgery, the proportion of patients in this population will increase. Atrial fibrillation has been shown to be a poor prognostic factor in several surgical situations. The aim of our study was to assess long-term mortality among patients with preoperative AF under various cardiac surgery settings, with a particular emphasis on the strategy of coronary revascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation referred for cardiac surgery in the 5 Polish participating centers.
Key inclusion criteria (2 listed)
- Referred for heart surgery,
- preoperative atrial fibrillation
Key exclusion criteria (1 listed)
- age<18 years old
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
Death from any cause
Time frame: 2008-2020
Through polish national health fund we are able to determine patient status (dead or alive)
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 27 Apr 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Nicolaus Copernicus University.
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 1 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Death from any cause (time frame: 2008-2020). 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 27 Apr 2021.