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

University of Massachusetts, Worcester

Status: Invitation-only

Conditions: Vascular Closure; Pacemaker Implantation; Leadless Pacemaker

Treatments: Device: percutaneous suture mediated closure; Device: Figure of Eight Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT06837870

STUDY00002172

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

SMC

Experimental group

Description:

Percutaneous suture mediated closure group

Treatment:

Device: percutaneous suture mediated closure

MC

Active Comparator group

Description:

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

Treatment:

Device: Figure of Eight Suture