Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants

Heart Failure Clinical Trial

— TUFF  

Official title:

Ultrasound-guided Venous Access, Using a Wireless Probe, for Pacemaker and Defibrillator Implants - a Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867460
• Other study ID #: TUFF-study
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Pacemaker- and defibrillator lead implants typically involve vascular access via the left cephalic, axillar or subclavian vein. Gaining access is usually straight forward for an experienced surgeon/implanter, but can be difficult in a minority of cases, or for implanters with less experience. Complications include arterial puncture, pneumothorax and local bleeding or hematoma. Traditionally cephalic vein cut-down is the first choice, but is only available in 70% of cases, and for more complex procedures involving three electrodes, an additional access is always required.

Ultrasound guidance is very common in other vascular access areas such as femoral artery, radial artery and internal jugular vein, but has not gained widespread acceptance in pacemaker procedures. High quality studies, demonstrating superiority or non-inferiority over other access methods are lacking.

The present study will include all comer 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). Implanters with various degrees of ultrasound experience and pacemaker surgery experience will participate in the study. All implanters will receive a 2-hour training lecture and additional hands-on training for the first 3 cases, by an ultrasound-experienced anaesthesiologist.

Access time and success rate will be recorded, and all acute complications will be recorded. Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured. Outcome data will be analyzed for the entire cohort, but also stratified for implanter and excluding the first 10 cases for each implanter, to compensate for various experience and individual learning curve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned pacemaker or implantable defibrillator surgery with at least one new transvenously placed lead.

Exclusion Criteria:

• Difficult vascular access known before surgery, where special access technique is planned or required.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• AV Block
• Cardiac Arrhythmia
• Heart Failure

Intervention

Procedure:
• Ultrasound guided venous access
Access of the axillary vein using ultrasound guidance.

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean time to complete venous access	Time from start of vascular access attempt to achieved access for the required number access points (ie number of leads)	Peroperatively
Secondary	Mean time to first venous access	Time from start of vascular access attempt to achieved access for the first introducer or lead	Peroperatively
Secondary	Successrate for full venous access	Percentage of cases with achieved full venous access using the assigned technique, without having to change technique	Peroperatively
Secondary	Successrate for full venous access within 3 minutes	Percentage of cases with achieved full venous access within 3 minutes, using the assigned technique, without having to change technique	Peroperatively
Secondary	Full venous access without any complication	Percentage of full venous access without any complication (including arterial puncture, pneumothorax, hemothorax, local hematoma and other acute complications)	Peroperatively within 24 hours