Not provided
Not provided
Not provided
Not provided
DSMB recommendation
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Active Comparator | Ultrasound guided venous access during AF ablation |
|
| Control | No Intervention | Conventional venous puncture guided by palpation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided venous access during AF ablation | Other | Ultrasound guided venous access during AF ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days |
Not provided
Not provided
Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neda Tarighi, Doctor | CCB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boris Schmidt | Frankfurt am Main | Hesse | 60431 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41979041 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
Not provided
Not provided
Investigator-initiated, prospective, randomized, interventional, multicenter trial
Not provided
Not provided
Not provided
| D055585 |
| Physical Phenomena |