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Clinical Trials/NCT02657590
NCT02657590UnknownNot Applicable

Documentation of Cardiac Arrhythmias After Open Heart Surgery

Ziv Beckerman MD0 sites200 target enrollmentStarted: March 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Primary Endpoint
Arrhythmia

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Arrhythmia

Time Frame: 6 weeks

Documention of arrhythmias in patients after open heart surgery during the six (6) weeks after release

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ziv Beckerman MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ziv Beckerman MD

cardiac surgeon

Rambam Health Care Campus

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