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

N/AEnrolling By InvitationNCT06837870

University of Massachusetts, Worcester50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vascular Closure Pacemaker Implantation Leadless Pacemaker

Interventions

percutaneous suture mediated closureDEVICE

Vascular closure with a commercially available SMC device.

Figure of Eight SutureDEVICE

Manual Compression with Figure of Eight Suture (control).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UMass Chan Medical School

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Time to Hemostasis

Time from sheath pull to hemostasis.

Time frame: During the procedure.

Secondary Outcomes

Time to discharge eligibility

Time from sheath pull to eligibility for discharge.

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

Major access related complications

Composite and individual access related complications

Time frame: 0 and 30 days

Minor access related complications

Composite and individual access related complications

Time frame: 0 and 30 days

Patient reported outcomes

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).

Time frame: 0 and 30 days

Costs

Direct and indirect procedure and peri-procedural cost data

Time frame: 0 and 30 days

Data from ClinicalTrials.gov

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