Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants (TUFF)
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|ClinicalTrials.gov Identifier: NCT04867460|
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : April 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrhythmia Heart Failure AV Block||Procedure: Ultrasound guided venous access||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 randomization|
|Masking:||None (Open Label)|
|Official Title:||Ultrasound-guided Venous Access, Using a Wireless Probe, for Pacemaker and Defibrillator Implants - a Randomized Study|
|Actual Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Ultrasound guided venous access
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.
Procedure: Ultrasound guided venous access
Access of the axillary vein using ultrasound guidance.
No Intervention: Standard of care
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.
- Mean time to complete venous access [ Time Frame: Peroperatively ]Time from start of vascular access attempt to achieved access for the required number access points (ie number of leads)
- Mean time to first venous access [ Time Frame: Peroperatively ]Time from start of vascular access attempt to achieved access for the first introducer or lead
- Successrate for full venous access [ Time Frame: Peroperatively ]Percentage of cases with achieved full venous access using the assigned technique, without having to change technique
- Successrate for full venous access within 3 minutes [ Time Frame: Peroperatively ]Percentage of cases with achieved full venous access within 3 minutes, using the assigned technique, without having to change technique
- Full venous access without any complication [ Time Frame: Peroperatively within 24 hours ]Percentage of full venous access without any complication (including arterial puncture, pneumothorax, hemothorax, local hematoma and other acute complications)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867460
|Skane University Hospital||Recruiting|
|Contact: Rasmus Borgquist +4646171010 firstname.lastname@example.org|