Catch me if You Can - the Individual Relationship Between... | NCT04586881

Studies
Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis

NCT04586881

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Status

Completed

Last Update Posted

Mar 17, 2023Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Oct 7, 2020

First Submission Date that Met QC Criteria

Oct 7, 2020

First Posted Date

Oct 14, 2020Actual

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

Mar 16, 2023

Last Update Posted Date

Mar 17, 2023Actual

Name	Class
Biosense Webster, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

Single center observational study to compare the relationship between atrial fibrosis and potential ablation targets from CARTOFINDER.

Detailed Description

A total number of 30 patients will undergo catheter Ablation for persistent AF. Pre-procedural cardiac MRI will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. CARTOFINDER-guided mapping will be performed during the ablation procedure followed by AF ablation. The individual relationship between atrial fibrosis and potential ablation targets will be accessed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Measure	Description	Time Frame
AF recurrence	recurrence of atrial fibrillation after catheter ablation	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing their 1st AF ablation procedure for persistent atrial fibrillation (AF) as per recent Heart Rhythm Society (HRS) consensus document
Able to understand and willing to sign the Informed Consent Form.
Age ≥18 years.

Exclusion Criteria:

Contraindication for DE-MRI with a full dose of Gadolinium-based contrast agent.
Previous left atrial ablation or surgical procedure
Renal failure with CrCl <60 ml/min
Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception
Mental or physical inability to take part in the study
Uncontrolled hypertension
Morbid obesity (BMI > 35), or inability to be placed in MRI due to body mass.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A total of 20 consecutive patients with drug-refractory persistent AF will be included in this prospective observational analysis. AF will be defined as persistent if episodes lasted > 7 days or required electrical or pharmacological cardioversion after ≥ 48 h from onset. All patients will be treated for AF at the Heart and Diabetes Center NRW, Bad Oeynhausen, Germany. Written informed will be obtained from each patient, the study concept complies with the Declaration of Helsinki and the institutional review board already approved the study design. Catheter ablation will be performed under deep sedation. In all patients preprocedural Magnetic Resonance Imaging (MRI) will be performed to guide the intervention, visualize the individual amount and distribution of fibrosis and to visualize the anatomical location and course of the esophagus.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum		Bad Oeynhausen		32545	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37885302	Derived	Guckel D, Piran M, Bergau L, Hamriti ME, Fink T, Sciacca V, Reil JC, Braun M, Khalaph M, Imnadze G, Kramer K, Friedrich S, Ruhl J, Korperich H, Sommer P, Sohns C. The individual relationship between atrial fibrillation sources from CARTOFINDER mapping and atrial cardiomyopathy: The catch me if you can trial. Pacing Clin Electrophysiol. 2023 Dec;46(12):1553-1564. doi: 10.1111/pace.14847. Epub 2023 Oct 27.

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