ACT-Measurement at Different Location During Left Atrial Ablation Procedures

NCT ID: NCT05040035

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-26

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ACT measurement

Measurement of active clotting time (ACT)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Internistisches Klinikum Munchen Sud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clemens Jilek, MD

Role: PRINCIPAL_INVESTIGATOR

Internistisches Klinikum Munchen Sud

Thorsten Lewalter, Prof

Role: STUDY_DIRECTOR

Internistisches Klinikum Munchen Sud

Locations

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Internistisches Klinikum München Süd

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Clemens Jilek, PD Dr

Role: CONTACT

+49 89 72400 ext. 0

Anna Hollweg

Role: CONTACT

+49 89 72400 ext. 4361

Facility Contacts

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Clemens Jilek, MD

Role: primary

+498972400

Anna Hollweg

Role: backup

+498972400

Other Identifiers

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ACT_IKMS_1

Identifier Type: -

Identifier Source: org_study_id

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