Monitoring brain blood flow during heart procedure for atrial fibrillation
Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study
This study is trying to see how often small blood clots travel to the brain during a heart procedure for atrial fibrillation and which techniques might make this risk higher.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05048004 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the frequency of cerebral embolization during pulmonary vein isolation (PVI) in patients with atrial fibrillation. Using continuous transcranial Doppler ultrasound, the study will monitor cerebral blood flow and detect microembolic signals throughout the PVI procedure. The research will compare different ablation techniques and anticoagulation regimes to identify which steps are associated with an increased risk of cerebral ischemia. The findings could help improve patient safety during catheter-based ablation procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with atrial fibrillation undergoing their first catheter-based ablation.
Not a fit: Patients who are pregnant or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to enhanced safety protocols during atrial fibrillation treatments, reducing the risk of stroke and cognitive decline.
How similar studies have performed: Previous studies have indicated potential risks associated with catheter-based treatments, but this specific approach using continuous TCD monitoring is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin * age 18 years or older Exclusion Criteria: * pregnancy * patient unable to provide written informed consent
Where this trial is running
Berlin
- Charité-University Medicine Berlin, Campus Benjamin Franklin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Christian H Nolte, MD — Charite University, Berlin, Germany
- Study coordinator: Tim B Brämswig, MD
- Email: tim-bastian.braemswig@charite.de
- Phone: +4930450560624
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.