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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06837870

Acronym

PERCLOSE-LP

Enrollment

Registered

2025-02-20

Start date

2025-07-11

Completion date

2027-01-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Closure, Pacemaker Implantation, Leadless Pacemaker

Keywords

perclose, percutaneous closure, leadless pacemaker, venous access

Brief summary

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.

Interventions

DEVICEpercutaneous suture mediated closure

Vascular closure with a commercially available SMC device.

DEVICEFigure of Eight Suture

Manual Compression with Figure of Eight Suture (control).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to Hemostasis	During the procedure.	Time from sheath pull to hemostasis.

Secondary

Measure	Time frame	Description
Time to discharge eligibility	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.
Major access related complications	0 and 30 days	Composite and individual access related complications
Minor access related complications	0 and 30 days	Composite and individual access related complications
Patient reported outcomes	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).
Costs	0 and 30 days	Direct and indirect procedure and peri-procedural cost data

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026