Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants
Key facts
- Who runs it
- Region Skane
- Where
- Sweden1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 58 people enrolled
- Started
- 1 Apr 2021
- Ended
- 27 Feb 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Ultrasound guided venous access
- Record updated
- 4 March 2025
- Why it stopped
- Recruitment too slow. Unrealistic to finish study with full recruitment.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Planned pacemaker or implantable defibrillator surgery with at least one new transvenously placed lead
Who cannot take part
- Difficult vascular access known before surgery, where special access technique is planned or required
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The study will include patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. A 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (Siemens Freestyle). Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured.
The 2 groups in the trial
- Ultrasound guided venous accessTreatment being tested
Vascular access of the axillary vein will be performed using an ultrasound system (Siemens Acuson Freestyle) with a wireless vascular ultrasound probe (L8-3 or L13-5). One or more vascular punctures will be performed, as needed.
- Standard of careNo study treatment, for comparison
Vascular access of the axillary or subclavian vein will be performed using anatomical landmarks, fluoroscopy and/or injection of X-ray contrast in the antecubital vein, at the choice of the implanter. One or more vascular punctures will be performed, as needed.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ultrasound-guided Venous Access, Using a Wireless Probe, for Pacemaker and Defibrillator Implants - a Randomized Study
- Record updated
- 4 March 2025