ACT-Measurement at Different Location During Left Atrial Ablation Procedures

Study Overview
=================
Brief Summary
-----------------
Ablation of atrial fibrillation is standard therapy for symptomatic patients or patients with severely reduced systolic left ventricular ejection fraction. Complications of the procedure are ischemic thrombembolic stroke. Therefore periprocedural treatment with heparin is administered to acchieve a therapeutic anticoagulation. The efficacy of anticoagulation is measured by active-clotting time (ACT) which is measured with blood drawn mostly from the V. femoralis. Despite controlled anticoagulation periprocedural stroke is published with an incidence of up to 2% and asymptomatic cerebral embolization from 2% to 15%. The ACT-Trial has two aims: Analysis of the influence of the localization of blood drawing on the measured ACT: blood from central venous line, from LA and from LAA. Dependency of the ACT measured in the blood of the LAA with regard to anatomic und functional LAA-measurements. Patients will be included scheduled for left atrial ablation procedure and will be divided in two groups: atrial fibrillation at time of procedure and sinus rhythm at time of procedure.

Official Title
-----------------
Influence of Localization of ACT-measurement and Influence of LAA on ACT Among Patients Undergoing Left Atrial Ablation Procedure.

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

Intervention / Treatment
-----------------
* Diagnostic Test: ACT measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients aged 18 until 80 years with atrial fibrillation scheduled for left atrial ablation procedure (according to 20216 ESC Guidelines for the management of atrial fibrillation and/or 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation 3. signed informed consent. 4. hemoglobin >10 g/dl in Messungen up to 8 weeks before inclusion. Exclusion criteria: Incompliance or contraindication of oral anticoagulation prior to ablation procedure.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ACT measurement|Measurement of active clotting time (ACT)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of mean and median values of ACT measurements from LA und LAA and dependency on anatomic and functional LAA parameters among patients in sinus rhythm. | Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured at the same time. | During ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target values of ACT measured in central venous line, LA and LAA among patients with sinus rhythm | Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured with regard to target ACT over time during ablation procedure among patients with sinus rhythm. | During ablation procedure | 
| Target values of ACT measured in central venous line, LA and LAA among patients with atrial fibrillation | Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured with regard to target ACT over time during ablation procedure among patients with atrial fibrillation. | During ablation procedure | 
| Dynamics of ACT values over time from samples taken from central venous line, LA and LAA among patients with sinus rhythm | Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured with regard to time behaviour during ablation procedure among patients with sinus rhythm. | During ablation procedure | 
| Dynamics of ACT values over time from samples taken from central venous line, LA and LAA among patients with atrial fibrillation | Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured with regard to time behaviour during ablation procedure among patients with atrial fibrillation. | During ablation procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anticoagulation, ablation, atrial fibrillation, ACT