Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT06837870
Status
Enrolling By Invitation

Conditions

  • Leadless Pacemaker
  • Pacemaker Implantation
  • Vascular Closure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • percutaneous suture mediated closure — DEVICE
    Vascular closure with a commercially available SMC device.
  • Figure of Eight Suture — DEVICE
    Manual Compression with Figure of Eight Suture (control).

Study Details

The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker implantation.

Key Dates

Start date
Jul 11, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SMC
    Percutaneous suture mediated closure group
  • Active Comparator: MC
    Manual Compression (with a figure-of-eight) closure group (i.e., control).

Primary Outcome Measure

Time to Hemostasis [ Time Frame: During the procedure. ]

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Chan Medical SchoolWorcesterMassachusetts01655-

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By research site
UMass Chan Medical School· Worcester, MA

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