Documentation of Cardiac Arrhythmias After Open Heart Surgery

March 16, 2016 updated by: Ziv Beckerman MD
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients aged 18 and over who underwent open-heart surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arrhythmia
Time Frame: 6 weeks
Documention of arrhythmias in patients after open heart surgery during the six (6) weeks after release
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ziv Becerman, MD, Rambam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • v.01_07.09.2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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