Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants (TUFF)

• ClinicalTrials.gov Identifier: NCT04867460
• Recruitment Status: Recruiting
• First Posted: April 30, 2021
• Last Update Posted: April 11, 2024
• Sponsor: Region Skane
• Information provided by (Responsible Party): Region Skane

Tracking Information

• First Submitted Date: April 27, 2021
• First Posted Date: April 30, 2021
• Last Update Posted Date: April 11, 2024
• Actual Study Start Date: April 1, 2021
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2021)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 27, 2021)

• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants
• Official Title: Ultrasound-guided Venous Access, Using a Wireless Probe, for Pacemaker and Defibrillator Implants - a Randomized Study
• Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

1:1 randomization

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Cardiac Arrhythmia
• Heart Failure
• AV Block

Intervention

Procedure: Ultrasound guided venous access

Access of the axillary vein using ultrasound guidance.

Study Arms

• 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.
  Intervention: Procedure: Ultrasound guided venous access
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 27, 2021): 375
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT04867460
• Other Study ID Numbers: TUFF-study
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Region Skane
• Original Responsible Party: Same as current
• Current Study Sponsor: Region Skane
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Region Skane
• Verification Date: April 2024