ACT-Measurement at Different Location During Left Atrial... | NCT05040035

Studies
ACT-Measurement at Different Location During Left Atrial Ablation Procedures

NCT05040035

Sponsor

Internistisches Klinikum Munchen Sud

Status

Unknown status

Last Update Posted

Sep 10, 2021Actual

Enrollment

190Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

ACT measurement

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2021Actual

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Oct 1, 2022Estimated

First Submitted Date

Aug 10, 2021

First Submission Date that Met QC Criteria

Sep 1, 2021

First Posted Date

Sep 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2021

Last Update Posted Date

Sep 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Analysis of the influence of the localization of blood drawing on the measured ACT: blood from central venous line, from LA and from LAA.
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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACT measurement	Diagnostic Test	Measurement of active clotting time (ACT)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with atrial fibrillation scheduled for left atrial ablation procedure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clemens Jilek, PD Dr	Contact	+49 89 72400	0	research@jilek.de
Anna Hollweg	Contact	+49 89 72400	4361	anna.hollweg@gmx.net

Overall Officials

Name	Affiliation	Role
Clemens Jilek, MD	Internistisches Klinikum Munchen Sud	Principal Investigator
Thorsten Lewalter, Prof	Internistisches Klinikum Munchen Sud	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Internistisches Klinikum München Süd	Recruiting	Munich	Bavaria	81379	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided