Posterior pericardiotomy for prevention of atrial fibrillation and pericardial effusion after aortic valve replacement
| ISRCTN | ISRCTN11129539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11129539 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/12/2013
- Registration date
- 08/01/2014
- Last edited
- 12/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Scientific
140, Rossiyskaya str.
Krasnodar
350086
Russian Federation
| vasily.kaleda@gmail.com |
Study information
| Study design | Single-centre non-blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The efficacy of posterior pericardiotomy in prevention of atrial fibrillation and pericardial effusion after aortic valve replacement |
| Study hypothesis | The hypothesis is that posterior pericardiotomy can reduce the incidence of atrial fibrillation and pericardial effusion after aortic valve replacement. |
| Ethics approval(s) | Kuban State Medical University Ethics Comimttee, 01/10/2013, Protocol #22 |
| 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 |
| Primary outcome measure | 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 study start date | 17/10/2013 |
| Overall study end date | 17/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 69 Years |
| Sex | Both |
| Target number of participants | 150 |
| Participant inclusion criteria | 1. Age 18-69 years 2. Informed consent obtained 3. Isolated primary aortic valve replacement |
| 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
Study participating centre
350086
Russian Federation
Sponsor information
University/education
4, Sedina str.
Krasnodar
350063
Russian Federation
| Phone | +7 918 377 8155 |
|---|---|
| corpus@ksma.ru | |
| Website | http://www.ksma.ru |
"ROR" |
https://ror.org/04wa91k02 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/07/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/02/2017 | Yes | No |
Editorial Notes
12/07/2017: Publication reference added. Sponsor telephone added. Publication and dissemination plan added, as well as participant level data sharing statement.
