NCT06403527

Brief Summary

To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,075

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

May 3, 2024

Last Update Submit

February 5, 2026

Conditions

Puncture for Safe Atrial Fibrillation Ablation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Interventional arm

ACTIVE COMPARATOR

Ultrasound guided venous access during AF ablation

Other: Ultrasound guided venous access during AF ablation

Control

NO INTERVENTION

Conventional venous puncture guided by palpation

Interventions

Ultrasound guided venous access during AF ablationOTHER

Ultrasound guided venous access during AF ablation

Also known as: Ultrasound
Interventional arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Signed written informed consent
  • Planned transvenous catheter ablation procedure for AF or left atrial tachycardia
  • Willingness to participate in follow-up

You may not qualify if:

  • 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.
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boris Schmidt

Frankfurt am Main, Hesse, 60431, Germany

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Neda Tarighi, Doctor

    CCB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Investigator-initiated, prospective, randomized, interventional, multicenter trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 8, 2024

Study Start

March 3, 2024

Primary Completion

February 4, 2026

Study Completion

February 4, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

DE(1)