ACT-Measurement at Different Location During Left Atrial Ablation Procedures

Atrial Fibrillation Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040035
• Other study ID #: ACT_IKMS_1
• Status: Recruiting
• Start date: August 26, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: Internistisches Klinikum Munchen Sud
• Contact: Clemens Jilek, PD Dr
• Phone: +49 89 72400
• Email: research[@]jilek.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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: 1. Analysis of the influence of the localization of blood drawing on the measured ACT: blood from central venous line, from LA and from LAA. 2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• ACT measurement
Measurement of active clotting time (ACT)

Locations

Country	Name	City	State
Germany	Internistisches Klinikum München Süd	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Internistisches Klinikum Munchen Sud

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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