Atrial Fibrillation and Diabetes Mellitus

NCT ID: NCT05873920

Last Updated: 2023-05-24

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-09

Study Completion Date

2025-05-31

Brief Summary

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Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.

Detailed Description

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A total number of 50 patients with diabetes mellitus will undergo radiofrequency-guided catheter ablation for atrial fibrillation. 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. The relationship between diabetes mellitus and individual atrial arrhythmia substrates as well as patients' outcome following catheter ablation will be analyzed.

Conditions

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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing their 1st radiofrequency-guided catheter ablation for atrial fibrillation
* Diabetes mellitus
* 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
* 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
* 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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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

Bad Oeynhausen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Denise Guckel, MD

Role: CONTACT

49 5731 971258

Astrid Kleemeyer

Role: CONTACT

49 5731 971258

Facility Contacts

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Astrid Kleemeyer

Role: primary

49 5731 97 ext. 1258

Other Identifiers

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HDZ-ER_004_DG

Identifier Type: -

Identifier Source: org_study_id

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