Impact of catheter ablation on stroke and bleeding risk scores
Impact of Catheter Ablation of Atrial Tachyarrhythmias on ABC Stroke and ABC Bleeding Risk Scores
This study is trying to see how catheter ablation for heart rhythm problems affects the risk of stroke and bleeding in people who are having the procedure for the first time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 1 site (Hanover, Lower Saxony) |
| Trial ID | NCT05635864 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how catheter ablation for symptomatic atrial tachyarrhythmias, such as atrial fibrillation and atrial flutter, affects the ABC-stroke and ABC-bleeding risk scores. Participants scheduled for their first catheter ablation will have blood samples collected at multiple time points before and after the procedure to assess changes in these risk scores. Continuous heart rhythm monitoring will be conducted using implantable devices and wearable technology over a six-month period. The study will analyze the differences in risk scores in relation to any recurrences of atrial fibrillation or atrial flutter.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are experiencing symptomatic atrial tachyarrhythmias and are scheduled for their first catheter ablation.
Not a fit: Patients with a history of transient ischemic attack (TIA) or stroke, previous atrial ablation, or those ineligible for catheter ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification for patients with atrial fibrillation, potentially enhancing clinical decision-making regarding anticoagulation therapy.
How similar studies have performed: Previous studies have indicated that combining clinical parameters with biomarkers for risk assessment in atrial fibrillation has shown promise, suggesting this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic atrial tachyarrhythmias (atrial fibrillation, atrial flutter) * Planned for 1st right or left atrial ablation * Informed consent * at least 18 years Exclusion Criteria: * Previous left or right atrial ablation * Ineligibility for catheter ablation * History of TIA / stroke * \< 18 years * LA thrombus formation or history of thrombus formation
Where this trial is running
Hanover, Lower Saxony
- Hannover Medical School — Hanover, Lower Saxony, Germany (Recruiting)
Study contacts
- Principal investigator: David Duncker, Prof. Dr. — Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover
- Study coordinator: David Duncker, Prof. Dr.
- Email: duncker.david@mh-hannover.de
- Phone: +49511-53282604
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.