Using ultrasound to improve safety in heart procedure access
Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures
This study tests if using ultrasound to guide doctors during heart procedures can help reduce complications for patients undergoing treatment for atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1836 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardioangiologisches Centrum Bethanien Academic / other |
| Locations | 1 site (Frankfurt, Hessen) |
| Trial ID | NCT06403527 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of ultrasound-guided venous puncture in reducing complications associated with access sites during atrial fibrillation ablation procedures. Participants will undergo a planned transvenous catheter ablation, and the study aims to determine if the ultrasound technique enhances safety compared to traditional methods. The study will involve patients aged 18 and older who provide informed consent and are willing to participate in follow-up assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for transvenous catheter ablation for atrial fibrillation or left atrial tachycardia.
Not a fit: Patients who require arterial access, have coagulation disorders, or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of complications during atrial fibrillation ablation procedures.
How similar studies have performed: Previous studies have shown that ultrasound guidance can improve safety in various medical procedures, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion Criteria 1. Age ≥18 years 2. Signed written informed consent 3. Planned transvenous catheter ablation procedure for AF or left atrial tachycardia 4. Willingness to participate in follow-up Exclusion Criteria 1. Patient is unable or unwilling to provide informed consent 2. Planned/required arterial access (e.g. for blood pressure monitoring) 3. Patient has contra-indication to oral anticoagulation 4. Known coagulation disorder or Thrombocytopenia \<150.000/ul. 6. Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index \< 1%), 7. Patient is included in another clinical trial 8. Inability to comply with the study procedures
Where this trial is running
Frankfurt, Hessen
- Boris Schmidt — Frankfurt, Hessen, Germany (Recruiting)
Study contacts
- Study coordinator: Boris Schmidt, Prof.
- Email: b.schmidt@ccb.de
- Phone: 069945028
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.