An observational study in Atrial Fibrillation, Arrhythmias, Cardiac and Heart Diseases, sponsored by Heart and Diabetes Center North-Rhine Westfalia. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Heart and Diabetes Center North-Rhine Westfalia · Observational
Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 50 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Heart and Diabetes Center North-Rhine Westfalia is the lead sponsor of 33 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
atrial fibrillation recurrence
atrial fibrillation recurrence following catheter ablation
Time frame: 12 months
Started May 2023 (actual). Primary completion is estimated for Dec 2024, 19 months after the start.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 19 months is below that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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Heart and Diabetes Center North-Rhine Westfalia