Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures

Not Applicable

Recruiting

• Conditions: Puncture for Safe Atrial Fibrillation Ablation
• Interventions: Other: Ultrasound guided venous access during AF ablation

• Registration Number: NCT06403527
• Lead Sponsor: Cardioangiologisches Centrum Bethanien

Brief Summary

To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-03
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-12-03
• Study Completion: 2025-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1836

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.

5. 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional arm	Ultrasound guided venous access during AF ablation	Ultrasound guided venous access during AF ablation

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Boris Schmidt; 🇩🇪 Frankfurt, Hessen, Germany