Cardiac ArrhythmiasNCT02657590
Documentation of Cardiac Arrhythmias After Open Heart Surgery
An observational study of Cardiac Arrhythmias, run by Ziv Beckerman MD.
Trial summary
This study aims at recording cardiac arrhythmias in patients after open heart surgery. The arrhythmias will be monitored during the entire first postoperative period, till six weeks after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Nov 2019
- 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: All patients aged 18 and over who underwent open-heart surgery.
Who may be able to join
- 18 years or older.
- Patients after open-heart surgery (any type of surgery).
Who cannot join
- Patients with internal pacemaker.
- patients with known basic arrhythmia (pre-surgery) or patients who are discharged with some arrhythmias.
- Patients with low response which it is expected that there will not be able to use the monitoring device
Trial locations and contacts
No sites are listed yet.
About this study
This study aims at recording cardiac arrhythmias in patients after open heart surgery. The arrhythmias will be monitored during the entire first postoperative period, till six weeks after surgery.
Read the detailed description
Approximately 30-50% of patients after cardiac surgery develop cardiac arrhythmias, most often atrial, and most frequently atrial fibrillation (AF).
Various risk factors, inter alia, the type of surgery itself are risk factors. The major additional risk factors for postoperative atrial fibrillation are: age, valvular involvement, length of cardiopulmonary bypass and cross-clamp times.
Postoperative atrial fibrillation is associated with increased length of stay, higher morbidity and mortality including stroke.
Documentation of postopertive atrial fibrillation is well gathered during the postopertive length of stay, but scarce information exists regarding the development and occurence of atrial arrhythmias after the patient's discharge.
Additionally, the various management protocols which exists with regard to postoperative atrial fibrillation, rely on continuous treatment of the patients with amiodarone or various other anti-arrhythmic agents for the initial postoperative period, and the initial first month after discharge.
So far there is not an unambiguous recommendation regarding the duration of treatment required with amiodarone after releasing the patient.
The aim of this study is to document and record cardiac arrhythmias in patients after open-heart surgery within the time window since the release from hospital and up to six weeks after surgery.
Results of the study will allow us to fully characterize postoperative arrhythmias and their risk factors.
- Conditions
- Cardiac Arrhythmias
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia
Documention of arrhythmias in patients after open heart surgery during the six (6) weeks after release
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Beckerman MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ziv Beckerman MD, Rambam Health Care Campus
- Investigators
- ziv Becerman, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657590
- Sponsor's protocol ID
- v.01_07.09.2015
- Status last verified
- Mar 2016
- First submitted
- 14 Jan 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of Cardiac Arrhythmias After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT02657590
- Acronym / sponsor ID
- v.01_07.09.2015
- Conditions
- Cardiac Arrhythmias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ziv Beckerman MDUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 18 Jan 2016 (estimated)
- 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.
This study aims at recording cardiac arrhythmias in patients after open heart surgery. The arrhythmias will be monitored during the entire first postoperative period, till six weeks after surgery.
Detailed description
Approximately 30-50% of patients after cardiac surgery develop cardiac arrhythmias, most often atrial, and most frequently atrial fibrillation (AF).
Various risk factors, inter alia, the type of surgery itself are risk factors. The major additional risk factors for postoperative atrial fibrillation are: age, valvular involvement, length of cardiopulmonary bypass and cross-clamp times.
Postoperative atrial fibrillation is associated with increased length of stay, higher morbidity and mortality including stroke.
Documentation of postopertive atrial fibrillation is well gathered during the postopertive length of stay, but scarce information exists regarding the development and occurence of atrial arrhythmias after the patient's discharge.
Additionally, the various management protocols which exists with regard to postoperative atrial fibrillation, rely on continuous treatment of the patients with amiodarone or various other anti-arrhythmic agents for the initial postoperative period, and the initial first month after discharge.
So far there is not an unambiguous recommendation regarding the duration of treatment required with amiodarone after releasing the patient.
The aim of this study is to document and record cardiac arrhythmias in patients after open-heart surgery within the time window since the release from hospital and up to six weeks after surgery.
Results of the study will allow us to fully characterize postoperative arrhythmias and their risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 and over who underwent open-heart surgery.
Key inclusion criteria (2 listed)
- 18 years or older.
- Patients after open-heart surgery (any type of surgery).
Key exclusion criteria (3 listed)
- Patients with internal pacemaker.
- patients with known basic arrhythmia (pre-surgery) or patients who are discharged with some arrhythmias.
- Patients with low response which it is expected that there will not be able to use the monitoring device
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
Arrhythmia
Time frame: 6 weeks
Documention of arrhythmias in patients after open heart surgery during the six (6) weeks after release
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
ziv Becerman, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by Ziv Beckerman MD.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziv Becerman, MD (97247772631, z_beckerman@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia (time frame: 6 weeks). 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 17 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.