Atrial Fibrillation and Diabetes Mellitus
Impact of Individual Atrial Arrhythmia Substrate on the Outcome Following Radiofrequency-Guided Catheter Ablation for Atrial Fibrillation in Patients With Diabetes Mellitus
1 other identifier
observational
50
1 country
1
Brief Summary
Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2023
CompletedFirst Submitted
Initial submission to the registry
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
May 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMay 24, 2023
May 1, 2023
1.6 years
May 16, 2023
May 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
atrial fibrillation recurrence
atrial fibrillation recurrence following catheter ablation
12 months
Eligibility Criteria
A total of 50 consecutive patients with diabetes mellitus and symptomatic atrial fibrillation will be included in this prospective observational analysis. All patients will be treated for atrial fibrillation at the Heart and Diabetes Center NRW, Bad Oeynhausen, Germany. Written informed will be obtained from each patient, the study concept complies with the Declaration of Helsinki and the institutional review board already approved the study design. Catheter ablation will be performed under deep sedation. In all patients preprocedural magnetic resonance imaging (MRI) will be performed prior to the intervention to visualize the individual amount and distribution of fibrosis and to visualize the anatomical location and course of the esophagus.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2023
First Posted
May 24, 2023
Study Start
May 9, 2023
Primary Completion
December 31, 2024
Study Completion
May 31, 2025
Last Updated
May 24, 2023
Record last verified: 2023-05