Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation. (PERCLOSE-LP)

March 25, 2026 updated by: Soroosh Kiani, University of Massachusetts, Worcester

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Chan Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMC
Percutaneous suture mediated closure group
Device: percutaneous suture mediated closure
Vascular closure with a commercially available SMC device.
Other Names:
  • PerClose, ProStyle
Active Comparator: MC
Manual Compression (with a figure-of-eight) closure group (i.e., control).
Device: Figure of Eight Suture
Manual Compression with Figure of Eight Suture (control).
Other Names:
  • Fo8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Hemostasis
Time Frame: During the procedure.
Time from sheath pull to hemostasis.
During the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.
Major access related complications
Time Frame: 0 and 30 days
Composite and individual access related complications
0 and 30 days
Minor access related complications
Time Frame: 0 and 30 days
Composite and individual access related complications
0 and 30 days
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).
0 and 30 days
Costs
Time Frame: 0 and 30 days
Direct and indirect procedure and peri-procedural cost data
0 and 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Periprocedurally. Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00002172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vascular Closure

Clinical Trials on percutaneous suture mediated closure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe