TerminatedNot Applicable

Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants

Stopped: Recruitment too slow. Unrealistic to finish study with full recruitment.

Sweden58 participantsStarted 2021-04-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean time to complete venous access

Timeframe: Peroperatively

Trial details

NCT IDNCT04867460

SponsorRegion Skane

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-27

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