Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures (ULYSSES)

Cardioangiologisches Centrum Bethanien

Status: Enrolling

Conditions: Puncture for Safe Atrial Fibrillation Ablation

Treatments: Other: Ultrasound guided venous access during AF ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06403527

ULYSSES

Details and patient eligibility

About

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

Enrollment: 1,836 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,836 participants in 2 patient groups

Interventional arm

Active Comparator group

Description:

Ultrasound guided venous access during AF ablation

Treatment:

Other: Ultrasound guided venous access during AF ablation

Control

No Intervention group

Description:

Conventional venous puncture guided by palpation