Puncture for Safe Atrial Fibrillation Ablation
Conditions
Brief summary
To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.
Interventions
OTHERUltrasound guided venous access during AF ablation
Ultrasound guided venous access during AF ablation
Sponsors
Cardioangiologisches Centrum Bethanien
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Investigator-initiated, prospective, randomized, interventional, multicenter trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of venous access site complications | 30 days | occurrence of venous access site complications until 30 days after the procedure defined as AV fistula, false aneurysm or access site bleeding requiring intervention (BARC 3 A or higher) |
Countries
Germany
Contacts
STUDY_CHAIRNeda Tarighi, Doctor
CCB
Outcome results
None listed