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

February 5, 2026 updated by: Cardioangiologisches Centrum Bethanien
To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1075

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60431
        • Boris Schmidt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interventional arm
Ultrasound guided venous access during AF ablation
Other: Ultrasound guided venous access during AF ablation
Ultrasound guided venous access during AF ablation
Other Names:
  • Ultrasound
No Intervention: Control
Conventional venous puncture guided by palpation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of venous access site complications
Time Frame: 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)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardioangiologisches Centrum Bethanien

Investigators

  • Study Chair: Neda Tarighi, Doctor, CCB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2024

Primary Completion (Actual)

February 4, 2026

Study Completion (Actual)

February 4, 2026

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULYSSES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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