Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants

NCT04867460 | Terminated

• 1 other identifier: TUFF-study
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmia; Heart Failure; AV Block

Keywords

Pacemaker; Implantable defibrillator; Venous access; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean time to first venous access

  Peroperatively

• Successrate for full venous access

  Peroperatively

• Successrate for full venous access within 3 minutes

  Peroperatively

• Full venous access without any complication

  Peroperatively within 24 hours

Study Arms (2)

Ultrasound guided venous access

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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.

Interventions

Ultrasound guided venous access PROCEDURE

Access of the axillary vein using ultrasound guidance.

Ultrasound guided venous access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospital

Lund, Sweden

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Failure; Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: April 1, 2021
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-04

Locations

SE (1)