ACT-Measurement at Different Location During Left Atrial Ablation Procedures

NCT05040035 | Unknown DMC

• 1 other identifier: ACT_IKMS_1
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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. 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. 2.Dependency of the ACT measured in the blood of the LAA with regard to anatomic und functional LAA-measurements.

Conditions

Atrial Fibrillation

Keywords

anticoagulation; ablation; atrial fibrillation; ACT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Target values of ACT measured in central venous line, LA and LAA 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

  During ablation procedure

• Dynamics of ACT values over time from samples taken from central venous line, LA and LAA 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

  During ablation procedure

Interventions

ACT measurement DIAGNOSTIC_TEST

Measurement of active clotting time (ACT)

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation scheduled for left atrial ablation procedure

You may not qualify if:

• Incompliance or contraindication of oral anticoagulation prior to ablation procedure.

Sponsors & Collaborators

• Internistisches Klinikum Munchen Sud: lead

Study Sites (1)

Internistisches Klinikum München Süd

Munich, Bavaria, 81379, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemens Jilek, MD

  Internistisches Klinikum Munchen Sud

  PRINCIPAL INVESTIGATOR

• Thorsten Lewalter, Prof

  Internistisches Klinikum Munchen Sud

  STUDY DIRECTOR

Central Study Contacts

Clemens Jilek, PD Dr

CONTACT

+49 89 72400; research@jilek.de

Anna Hollweg

CONTACT

+49 89 72400; anna.hollweg@gmx.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 10, 2021
• Study Start: August 26, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)