Clinical trial NCT05040035: ACT-Measurement at Different Location During Left Atrial Ablation Procedures
Official title: Influence of Localization of ACT-measurement and Influence of LAA on ACT Among Patients Undergoing Left Atrial Ablation Procedure.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: anticoagulation
ablation
atrial fibrillation
ACT
Lead sponsor: Internistisches Klinikum Munchen Sud
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 190
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation scheduled for left atrial ablation procedure

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:

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.


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.

Primary outcomes:
measure: 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.
timeFrame: During ablation procedure
Secondary outcomes:
measure: Target values of ACT measured in central venous line, LA and LAA among patients with sinus rhythm
timeFrame: During ablation procedure
measure: Target values of ACT measured in central venous line, LA and LAA among patients with atrial fibrillation
timeFrame: During ablation procedure
measure: Dynamics of ACT values over time from samples taken from central venous line, LA and LAA among patients with sinus rhythm
timeFrame: During ablation procedure
measure: Dynamics of ACT values over time from samples taken from central venous line, LA and LAA among patients with atrial fibrillation
timeFrame: During ablation procedure
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Internistisches Klinikum München Süd
state: Bavaria
Study officials:
affiliation: Internistisches Klinikum Munchen Sud
name: Clemens Jilek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Internistisches Klinikum Munchen Sud
name: Thorsten Lewalter, Prof
role: STUDY_DIRECTOR
References: