Documentation of Cardiac Arrhythmias After Open Heart Surgery

NCT ID: NCT02657590

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-11-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Beckerman MD

OTHER

Sponsor Role: lead

Responsible Party

Ziv Beckerman MD

cardiac surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

ziv Becerman, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Hospital

Central Contacts

Ziv Becerman, MD

Role: CONTACT

z_beckerman@rambam.health.gov.il

97247772631

Daniel Haber, MA

Role: CONTACT

d_haber@rambam.health.gov.il

972-4-7772048

Other Identifiers

v.01_07.09.2015

Identifier Type: -

Identifier Source: org_study_id