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

NCT06837870 | Enrolling By Invitation FDA Device

• 1 other identifier: STUDY00002172
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Closure; Pacemaker Implantation; Leadless Pacemaker

Keywords

perclose; percutaneous closure; leadless pacemaker; venous access

Outcome Measures

Primary Outcomes (1)

• Time to Hemostasis

  Time from sheath pull to hemostasis.

  During the procedure.

Secondary Outcomes (5)

• Time to discharge eligibility

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

• Major access related complications

  0 and 30 days

• Minor access related complications

  0 and 30 days

• Patient reported outcomes

  0 and 30 days

• Costs

  0 and 30 days

Other Outcomes (1)

• Time to Ambulation

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

Study Arms (2)

SMC

EXPERIMENTAL

Percutaneous suture mediated closure group

Device: percutaneous suture mediated closure

MC

ACTIVE COMPARATOR

Manual Compression (with a figure-of-eight) closure group (i.e., control).

Device: Figure of Eight Suture

Interventions

percutaneous suture mediated closure DEVICE

Vascular closure with a commercially available SMC device.

Also known as: PerClose, ProStyle

SMC

Figure of Eight Suture DEVICE

Manual Compression with Figure of Eight Suture (control).

Also known as: Fo8

MC

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 20, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)