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

September 1, 2021 updated by: Internistisches Klinikum Munchen Sud

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81379
        • Recruiting
        • Internistisches Klinikum München SUD
        • Contact:
        • Contact:
          • Anna Hollweg
          • Phone Number: +498972400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: During ablation procedure
Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured at the same time.
During ablation procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Target values of ACT measured in central venous line, LA and LAA among patients with sinus rhythm
Time Frame: During ablation procedure
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
Time Frame: During ablation procedure
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
Time Frame: During ablation procedure
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
Time Frame: During ablation procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Internistisches Klinikum Munchen Sud

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clemens Jilek, MD, Internistisches Klinikum München SUD
  • Study Director: Thorsten Lewalter, Prof, Internistisches Klinikum München SUD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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