Atrial Fibrillation and Diabetes Mellitus

May 16, 2023 updated by: Heart and Diabetes Center North-Rhine Westfalia

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Herz- und Diabeteszentrum NRW
        • Contact:
        • Principal Investigator:
          • Denise Guckel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
atrial fibrillation recurrence
Time Frame: 12 months
atrial fibrillation recurrence following catheter ablation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZ-ER_004_DG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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