Impact of diabetes on outcomes after heart procedure for atrial fibrillation
Impact of Individual Atrial Arrhythmia Substrate on the Outcome Following Radiofrequency-Guided Catheter Ablation for Atrial Fibrillation in Patients With Diabetes Mellitus
This study looks at how having diabetes affects the results of a heart procedure for atrial fibrillation in patients who have it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heart and Diabetes Center North-Rhine Westfalia Academic / other |
| Locations | 1 site (Bad Oeynhausen) |
| Trial ID | NCT05873920 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze how diabetes mellitus affects patient outcomes following radiofrequency-guided catheter ablation for atrial fibrillation. A total of 50 patients with diabetes will undergo the procedure, and pre-procedural cardiac MRI will be conducted to assess fibrosis in the atria. The study will investigate the relationship between diabetes and the individual arrhythmia substrates, as well as the overall outcomes of the catheter ablation procedure.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diabetes mellitus who are undergoing their first catheter ablation for atrial fibrillation.
Not a fit: Patients with contraindications for MRI, previous ablation procedures, or significant obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with diabetes undergoing catheter ablation for atrial fibrillation.
How similar studies have performed: While studies on atrial fibrillation and diabetes exist, this specific approach focusing on the relationship between diabetes and arrhythmia substrates in the context of catheter ablation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bad Oeynhausen
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen, Germany (Recruiting)
Study contacts
- Study coordinator: Denise Guckel, MD
- Email: dguckel@hdz-nrw.de
- Phone: 49 5731 971258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.