Skip to content

Time to Access and vascular complications after venous access using standard of care needle vs. ultrasound needle in electrophysiological ablation procedures

Time to Access and vascular complications after venous access using standard of care needle vs. ultrasound needle in electrophysiological ablation procedures - EP-Puncture

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038053
Enrollment
1200
Registered
2025-10-06
Start date
2025-10-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I47.1

Interventions

Group 1: Use of the standard puncture needle set for ultrasound-guided puncture of the femoral vein for access during interventional cardiac ablation treatment Group 2: Use of a special puncture needl

Sponsors

Universität zu Köln, Uniklinik Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients capable of giving consent after providing written consent

Exclusion criteria

Exclusion criteria: lack of capacity to consent, or withdrawal of consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Occurrence of groin complications by means of clinical examination of the groin puncture site on the first post-interventional day; if abnormalities are found, duplex ultrasound of the groin - hematoma - aneurysm - AV-fistula

Secondary

MeasureTime frame
-Time to successful venous access (Skin penetration until insertion of all necessary sheaths) measured in seconds while groin puncture - postinterventional groin pain (numeric rating scale) on the first post-interventional day

Countries

Germany

Contacts

Public ContactDaniel Steven

Universitätsklinik Köln

daniel.steven@uk-koeln.de+4922147836967

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026