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OpenTrials
Enrolling by Invitation

NCT Number: NCT06837870

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

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.

Enrolling by Invitation

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Key information

Conditions

Vascular Closure Leadless Pacemaker Pacemaker Implantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 and older
  • Patients undergoing leadless pacemaker implant at UMass Chan Medical Center
  • Subjects able to understand and provide written informed consent.

Exclusion criteria

  • Patients who are pregnant
  • Patents who are not able to ambulate prior to the procedure
  • Other conditions that, in the opinion of the investigator constitute a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
  • Prisoners or wards of the state.

Treatment and study plan

percutaneous suture mediated closure

Device

Vascular closure with a commercially available SMC device.

Other names: PerClose, ProStyle

Figure of eight suture

Device

Manual Compression with Figure of Eight Suture (control).

Other names: Fo8

Primary outcomes

  1. Time to Hemostasis

    Time frame: During the procedure.

    Time from sheath pull to hemostasis.

Secondary outcomes

  1. Time to discharge eligibility

    Time frame: Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.

    Time from sheath pull to eligibility for discharge.

  2. Major access related complications

    Time frame: 0 and 30 days

    Composite and individual access related complications

  3. Minor access related complications

    Time frame: 0 and 30 days

    Composite and individual access related complications

  4. Patient reported outcomes

    Time frame: 0 and 30 days

    Patient reported outcomes of both a pain and satisfaction ascertained by a questionnaire reported as a total/composite score of all questions, as well as the score for each individual question on the questionnaire (rated on a likert scale).

  5. Costs

    Time frame: 0 and 30 days

    Direct and indirect procedure and peri-procedural cost data

Other outcomes

  1. Time to Ambulation

    Time frame: Periprocedurally. Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.

    Time from sheath pull to ambulation

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

A Randomized Comparison of Percutaneous Closure to a Figure-of-eight Suture With Manual Compression for Hemostasis of Large-bore Access for Leadless Pacemaker Implantation

Acronym: PERCLOSE-LP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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