READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks before the surgery. Frequency, burden, and possible risk factors will be described. During the operation direct contact epicardial mapping will be performed and tissue samples will be collected to identify an electrophysiological and a structural substrate for development of AF.

Detailed Description
-----------------
Background of the study: Postoperative atrial fibrillation (POAF) after cardiac surgery is a common (1 in 4) complication and associated with morbidity and mortality. Not all episodes of AF are noticed and detected, especially after discharge. several studies have shown high mortality in POAF patients, suggesting a progression in AF frequency. Objective of the study: To investigate the real incidence and burden of POAF. Afterwards a risk stratification of POAF is made. To identify a structural and electrophysiological substrate for the development of POAF and new onset AF during follow up. Study design: 140 patients will receive a Reveal device. After 3 and 12 months data will be subtracted from the device. 100 of these patient will undergo additional mapping and tissue biopsies during operation. Study population: All patients undergoing cardiac surgery without a history of AF and without a pacemaker will be invited to participate in the study. Primary study parameters/outcome of the study: Incidence of POAF until 3 months after CABG. Secondary study parameters/outcome of the study: Incidence of POAF until 12 months after CABG. Determine risk factors for early and late POAF. Detect pre-operative (unnoticed) episodes of AF. Determine a substrate for development of AF. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is a small risk of minor complications (hemorrhage and infection of the pocket).The device can be explanted easily if necessary. Ther is a burden of the im- and explantation of the device (local anesthesia, approx. 20 minutes). Patient will have to visit the out-hospital clinic twice. The operation will be prolonged by 30 minutes due to mapping.

Official Title
-----------------
READ-POAF Pilot Study. The Use of the Reveal XT as Device for Postoperative Atrial Fibrillation Detection After Cardiac Surgery

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing non emergency surgery Sinus rhythm on initial visit Exclusion Criteria: History of atrial fibrillation Internal pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post cardiac surgery<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atrial fibrillation (AF) | frequency, frequency distribution, and burden of AF | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atrial fibrillation (AF) | frequency, frequency distribution, burden of AF, AF substrate | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative atrial fibrillation, internal loop recorder, risk factors, coronary artery bypass surgery