Condition category
Surgery
Date applied
25/12/2013
Date assigned
08/01/2014
Last edited
09/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In patients who underwent a heart surgery called coronary artery bypass graft (CABG), posterior pericardiotomy (a surgical procedure carried out on the pericardium of the heart) has been shown to be protective against postoperative atrial fibrillation (abnormal heart rate after heart surgery). This study aims to find out whether it could help patients who underwent valve surgery.

Who can participate?
Patients admitted for aortic valve replacement surgery can participate in this study.

What does the study involve?
Patients are divided randomly into two groups. One group receives posterior pericardiotomy during the valve replacement surgery and the other group, called the control group, receives the standard surgical technique.

What are the possible benefits and risks of participating?
This technique may reduce the occurrence of postoperative atrial fibrillation and accumulation of fluid around the heart in patients who underwent aortic valve replacement surgery.

Where is the study run from?
This study is run from Ochapowski Regional Hospital, Russia.

When is the study starting and how long is it expected to run for?
The study started in October 2013 and is expected to run for 1.5 years.

Who is funding the study?
The study is funded by the Kuban State Medical University, Russia.

Who is the main contact?
Dr Vasily Kaleda
vasily.kaleda@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vasily Kaleda

ORCID ID

Contact details

140
Rossiyskaya str.
Krasnodar
350086
Russian Federation
vasily.kaleda@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The efficacy of posterior pericardiotomy in prevention of atrial fibrillation and pericardial effusion after aortic valve replacement

Acronym

Study hypothesis

The hypothesis is that posterior pericardiotomy can reduce the incidence of atrial fibrillation and pericardial effusion after aortic valve replacement.

Ethics approval

Kuban State Medical University Ethics Comimttee, 01/10/2013, Protocol #22

Study design

Single-centre non-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiac surgery – postoperative atrial fibrillation and pericardial effusion

Intervention

Patients will be randomised to two groups: intervention and control
1. Intervention group: will undergo posterior pericardiotomy in addition to conventional aortic valve replacement
2. Control group: will undergo only conventional aortic valve replacement

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Mortality
2. The incidence of stroke
3. The incidence of cardiac tamponade

Concerned to in-hospital period.

Secondary outcome measures

1. The incidence of atrial fibrillation, measured with 48-h ECG monitoring and then with daily ECG
2. The incidence of pericardial effusion measured by echo twice after removing chest tubes and before discharge
3. The incidence of left pleural effusion measured by echo twice after removing chest tubes and before discharge
4. Length of stay in hospital

Overall trial start date

17/10/2013

Overall trial end date

17/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-69 years
2. Informed consent obtained
3. Isolated primary aortic valve replacement

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Known history of atrial fibrillation before surgery
2. Amiodarone intake before surgery
3. Known history of thyrotoxicosis
4. Pericardial effusion with a maximum pericardial separation of more than 0.5 cm by transthoracic echocardiography (TTE) before surgery
5. Severe chronic obstructive pulmonary disease (COPD)
6. Left ventricular ejection fraction (LVEF) <30%
7. Left atrium (LA) diameter >50 mm
8. Pericardial adhesions
9. Any active inflammatory disease at the time of surgery (including active infection endocarditis)

Recruitment start date

17/10/2013

Recruitment end date

17/04/2015

Locations

Countries of recruitment

Russian Federation

Trial participating centre

140, Rossiyskaya str.
Krasnodar
350086
Russian Federation

Sponsor information

Organisation

Kuban State Medical University (Russia)

Sponsor details

4
Sedina str.
Krasnodar
350063
Russian Federation
corpus@ksma.ru

Sponsor type

University/education

Website

http://www.ksma.ru

Funders

Funder type

University/education

Funder name

Kuban State Medical University (Russia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes