Suspended

ULYSSESUltrasound Guided Venous Puncture for Safe Atrial Fibrillation Ablation

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Study Aim

This study aims to evaluate the safety of using ultrasound-guided venous puncture for atrial fibrillation ablation by observing the occurrence of venous access site complications within 30 days after the procedure.

What is being tested

Ultrasound guided venous access during AF ablation

Other
Who is being recruted

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: March 2024
See protocol details

Summary

Principal SponsorCardioangiologisches Centrum Bethanien
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 3, 2024

Actual date on which the first participant was enrolled.

The study examines whether using ultrasound to guide venous puncture can make atrial fibrillation ablation procedures safer. Atrial fibrillation is a common heart rhythm disorder, and ablation is a treatment that helps restore normal heart rhythm. However, there can be risks associated with accessing veins during this procedure. By using ultrasound, doctors might be able to minimize complications at the access site, potentially leading to safer outcomes for patients undergoing this treatment. Participants in the study will undergo the standard ablation procedure, but with the added use of ultrasound to guide the needle when accessing veins. The study will observe and record if there are fewer complications, such as bleeding or bruising, at the site where the vein is accessed. The main focus is on determining whether ultrasound guidance can effectively reduce these risks, improving the overall safety of the procedure.

Official TitleUltrasound Guyded Venous Puncture for Safe AF Ablation Procedures
Principal SponsorCardioangiologisches Centrum Bethanien
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

1075 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Age ≥18 years

Signed written informed consent

Planned transvenous catheter ablation procedure for AF or left atrial tachycardia

Willingness to participate in follow-up

7 exclusion criteria prevent from participating
Patient is included in another clinical trial

Known coagulation disorder or Thrombocytopenia <150.000/ul.

Inability to comply with the study procedures

Patient has contra-indication to oral anticoagulation

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Ultrasound guided venous access during AF ablation

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Boris Schmidt

Frankfurt am Main, GermanyOpen Boris Schmidt in Google Maps
SuspendedOne Study Center