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NCT05873920 Clinical Trial

Atrial Fibrillation and Diabetes Mellitus

Cardiovascular Diseases Clinical Trial

Official title:
Impact of Individual Atrial Arrhythmia Substrate on the Outcome Following Radiofrequency-Guided Catheter Ablation for Atrial Fibrillation in Patients With Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05873920
Other study ID # HDZ-ER_004_DG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 9, 2023
Est. completion date May 31, 2025

Study information
Verified date May 2023
Source Heart and Diabetes Center North-Rhine Westfalia
Contact Denise Guckel, MD
Phone 49 5731 971258
Email dguckel@hdz-nrw.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date May 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Herz- und Diabeteszentrum NRW Bad Oeynhausen

Sponsors (1)
Lead Sponsor Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary atrial fibrillation recurrence atrial fibrillation recurrence following catheter ablation 12 months
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