Suture Techniques for Pacemaker Implantation

(PERCLOSE-LP Trial)

Overseen By Senior Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Pregnancy, Non-ambulatory, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are getting a leadless pacemaker implanted at UMass Chan Medical Center and can understand and give written consent. Specific details on who cannot participate are not provided.

Inclusion Criteria

I am 18 years old or older.

I am getting a leadless pacemaker at UMass Chan Medical Center.

I can understand and have signed the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo leadless pacemaker implantation with either percutaneous suture-mediated closure or manual compression with a figure-of-eight suture

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and complications after the procedure

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Figure-of-eight Suture
• Percutaneous Closure

Trial Overview The study compares two methods to stop bleeding after implanting a leadless pacemaker: one uses a special suture device (SMC) while the other uses manual pressure with a figure-of-eight stitch (MC). Participants will be randomly assigned to either method.

How Is the Trial Designed?

Group I: SMC Experimental Treatment 1 Intervention

Percutaneous suture mediated closure group

Group II: MC Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+