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Documentation of Cardiac Arrhythmias After Open Heart Surgery

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ClinicalTrials.gov Identifier: NCT02657590
Recruitment Status : Not yet recruiting
First Posted : January 18, 2016
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Ziv Beckerman MD, Rambam Health Care Campus

Brief 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.

Condition or disease
Cardiac Arrhythmias

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Documentation of Cardiac Arrhythmias After Open Heart Surgery
Study Start Date : March 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Arrhythmia [ Time Frame: 6 weeks ]
    Documention of arrhythmias in patients after open heart surgery during the six (6) weeks after release



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients aged 18 and over who underwent open-heart surgery.
Criteria

Inclusion Criteria:

  1. 18 years or older.
  2. Patients after open-heart surgery (any type of surgery).

Exclusion Criteria:

  1. Patients with internal pacemaker.
  2. patients with known basic arrhythmia (pre-surgery) or patients who are discharged with some arrhythmias.
  3. Patients with low response which it is expected that there will not be able to use the monitoring device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657590


Contacts
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Contact: Ziv Becerman, MD 97247772631 z_beckerman@rambam.health.gov.il
Contact: Daniel Haber, MA 972-4-7772048 d_haber@rambam.health.gov.il

Sponsors and Collaborators
Ziv Beckerman MD
Investigators
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Principal Investigator: ziv Becerman, MD Rambam Hospital

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Responsible Party: Ziv Beckerman MD, cardiac surgeon, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02657590     History of Changes
Other Study ID Numbers: v.01_07.09.2015
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes