ACT-Measurement at Different Location During Left Atrial Ablation Procedures (ACT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: ACT measurement

• Study Type: Observational
• Enrollment (Anticipated): 190

Contacts and Locations

• Study Contact: Name: Clemens Jilek, PD Dr; Phone Number: +49 89 72400; Email: research@jilek.de
• Study Contact Backup: Name: Anna Hollweg; Phone Number: 4361 +49 89 72400; Email: anna.hollweg@gmx.net

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81379
      • Recruiting
      • Internistisches Klinikum München SUD
      • Contact: Clemens Jilek, MD; Phone Number: +498972400; Email: research@jilek.de
      • Contact: Anna Hollweg; Phone Number: +498972400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation scheduled for left atrial ablation procedure

Description

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.

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Internistisches Klinikum Munchen Sud
• Investigators: Principal Investigator: Clemens Jilek, MD, Internistisches Klinikum München SUD; Study Director: Thorsten Lewalter, Prof, Internistisches Klinikum München SUD

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; anticoagulation; ablation; ACT
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ACT_IKMS_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No