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Atrial Fibrillation and Diabetes Mellitus

Sponsor
Heart and Diabetes Center North-Rhine Westfalia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05873920
Collaborator
(none)
50
Enrollment
1
Location
24.7
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Individual Atrial Arrhythmia Substrate on the Outcome Following Radiofrequency-Guided Catheter Ablation for Atrial Fibrillation in Patients With Diabetes Mellitus
    Actual Study Start Date :
    May 9, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    May 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. atrial fibrillation recurrence [12 months]

      atrial fibrillation recurrence following catheter ablation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herz- und Diabeteszentrum NRW Bad Oeynhausen Germany 32545

    Sponsors and Collaborators

    • Heart and Diabetes Center North-Rhine Westfalia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heart and Diabetes Center North-Rhine Westfalia
    ClinicalTrials.gov Identifier:
    NCT05873920
    Other Study ID Numbers:
    • HDZ-ER_004_DG
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Cardiovascular Diseases
    Heart Diseases
    Arrhythmias, Cardiac
    Diabetes Mellitus
    Pathologic Processes

    Study Results

    No Results Posted as of May 24, 2023