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

Not Applicable

• Conditions: Vascular Closure; Pacemaker Implantation; Leadless Pacemaker

• Registration Number: NCT06837870
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-20
• Study Start: 2025-07-11
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-17
• Primary Completion: 2025-12
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Hemostasis	During the procedure.	Time from sheath pull to hemostasis.

Secondary Outcome Measures

Name	Time	Method
Major access related complications	0 and 30 days	Composite and individual access related complications
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.
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

Trial Locations

Locations (1)

UMass Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States