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

NCT ID: NCT04586881

Last Updated: 2023-03-17

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

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role collaborator

Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 37885302 (View on PubMed)

Other Identifiers

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HDZ_ER001_CS

Identifier Type: -

Identifier Source: org_study_id

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