Puncture for Safe Atrial Fibrillation AblationULYSSESNCT06403527
Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures
A study testing Ultrasound guided venous access during AF ablation in people with Puncture for Safe Atrial Fibrillation Ablation, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial summary
To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Puncture for Safe Atrial Fibrillation Ablation
- What is being tested?
- Ultrasound guided venous access during AF ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,075 participants
- Where
- 1 siteGermany
- Study dates
- 3 Mar 2024to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Signed written informed consent
- Planned transvenous catheter ablation procedure for AF or left atrial tachycardia
- Willingness to participate in follow-up
Who cannot join
- Patient is unable or unwilling to provide informed consent
- Planned/required arterial access (e.g. for blood pressure monitoring)
- Patient has contra-indication to oral anticoagulation
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.
- Being tested
- Ultrasound guided venous access during AF ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided venous access during AF ablationOther
Also called Ultrasound
Ultrasound guided venous access during AF ablation
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Active comparator | Ultrasound guided venous access during AF ablation Receives: Other: Ultrasound guided venous access during AF ablation |
| Control | No intervention | Conventional venous puncture guided by palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of venous access site complications
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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start3 Mar 2024
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Why it stopped: DSMB recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Puncture for Safe Atrial Fibrillation AblationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, prospective, randomized, interventional, multicenter trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,075 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neda Tarighi, Doctor, Study chair, CCB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403527
- Sponsor's protocol ID
- ULYSSES
- Acronym
- ULYSSES
- Status last verified
- Feb 2026
- First submitted
- 3 May 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schaack D, Chun KRJ, Neven K, Metzner A, Heeger C, Wakili R, Sultan A, Urbani A, Reinsch N, Rillig A, Rolfes H, Rottner L, Vogler J, Urbanek L, Hartl S, Kheir J, Marx JA, Lurz J, Gunawardene MA, Bordignon S, Fueting A, Govorov K, Rafiee F, Holzl M, Rocchetti M, Tohoku S, Schmidt B; ULYSSES Investigators. Ultrasound-guided vs conventional venous puncture for atrial fibrillation ablation: the ULYSSES trial. Eur Heart J. 2026 Apr 14:ehag291. doi: 10.1093/eurheartj/ehag291. Online ahead of print.
PubMed 41979041
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures
- ClinicalTrials.gov ID
- NCT06403527
- Acronym / sponsor ID
- ULYSSES / ULYSSES
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommendation
- Enrolment
- 1,075 participants (actual)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Investigator-initiated, prospective, randomized, interventional, multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Active comparator | Other: Ultrasound guided venous access during AF ablationUltrasound guided venous access during AF ablation |
| Control | No intervention | –Conventional venous puncture guided by palpation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
- Patient is unable or unwilling to provide informed consent
- Planned/required arterial access (e.g. for blood pressure monitoring)
- Patient has contra-indication to oral anticoagulation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided venous access during AF ablationAlso: UltrasoundUltrasound guided venous access during AF ablation | Other | Interventional arm |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: DSMB recommendation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 41979041Schaack D, Chun KRJ, Neven K, Metzner A, Heeger C, Wakili R, Sultan A, Urbani A, Reinsch N, Rillig A, Rolfes H, Rottner L, Vogler J, Urbanek L, Hartl S, Kheir J, Marx JA, Lurz J, Gunawardene MA, Bordignon S, Fueting A, Govorov K, Rafiee F, Holzl M, Rocchetti M, Tohoku S, Schmidt B; ULYSSES Investigators. Ultrasound-guided vs conventional venous puncture for atrial fibrillation ablation: the ULYSSES trial. Eur Heart J. 2026 Apr 14:ehag291. doi: 10.1093/eurheartj/ehag291. Online ahead of print.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neda Tarighi, Doctor study chair
CCB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided venous access during AF ablation in people with Puncture for Safe Atrial Fibrillation Ablation, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: DSMB recommendation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of venous access site complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.