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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for closing the vein after placing a leadless pacemaker. One method uses a special stitch device (percutaneous suture-mediated closure), while the other employs a simple hand-tied stitch (manual compression with a figure-of-eight suture). The goal is to determine which technique better aids healing. Individuals who have a leadless pacemaker implanted at UMass Chan Medical Center and can walk before the procedure may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery methods for future patients.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these suture techniques are safe for pacemaker implantation?

Research has shown that percutaneous closure is a safe method for closing large openings in blood vessels. One study successfully stopped bleeding in all cases using this technique. Another study confirmed the safety and effectiveness of the devices used for percutaneous closure. Additionally, past research highlights that this method reliably stops bleeding after certain heart procedures. These findings suggest that percutaneous closure is generally well-tolerated.

Specific data on the figure-of-eight suture technique is not available in the sources. However, the absence of a specific phase label implies that the technique is already considered safe enough for further research. Both methods appear to be safe options for patients considering participation in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing suture techniques for pacemaker implantation because it explores innovative methods to improve patient outcomes. Unlike the traditional manual compression method, which involves a figure-of-eight suture, the percutaneous suture-mediated closure offers a minimally invasive approach that could lead to quicker recovery times and less discomfort for patients. By potentially reducing complications like bleeding or infection, this new technique might enhance the overall safety and efficiency of pacemaker implantation procedures.

What evidence suggests that these suture techniques are effective for pacemaker implantation?

This trial will compare two suture techniques for pacemaker implantation: suture-mediated closure (SMC) and manual compression with a figure-of-eight closure. Research has shown that techniques like SMC are highly effective. Specifically, studies have demonstrated a 100% success rate in stopping bleeding, effectively preventing it. In addition to controlling bleeding, SMC has shortened bed rest time after certain heart procedures, potentially speeding up and easing recovery. These findings highlight the potential benefits of SMC for placing leadless pacemakers. ^{1 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11549639/

Double Perclose increases the efficiency of leadless ... Both closure techniques demonstrated 100% success rate in achieving hemostasis. In terms of efficiency outcomes, the DPP group exhibited shorter total in-room ...

2. heartrhythmopen.com heartrhythmopen.com/article/S2666-5018(24)00258-7/pdf

Double Perclose increases the efficiency of leadless ... This work represents the first attempt, to our knowledge, to compare outcomes between the 2 vascular closure techniques in LP patients. Further research is ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39377569/

Secondary analysis of a randomized clinical trial SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation.

4. withpower.com withpower.com/trial/phase-pacemaker-implantation-3-2025-32711

Suture Techniques for Pacemaker Implantation · Info for ... The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture ...

5. researchgate.net researchgate.net/publication/383692337_Double_Perclose_increases_the_efficiency_of_leadless_pacemaker_implantation_a_propensity_score-matched_analysis

(PDF) Double Perclose increases the efficiency of leadless ... Double Perclose increases the efficiency of leadless pacemaker implantation: A propensity score–matched analysis. August 2024; Heart Rhythm O2 5 ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.119.007258

Pivotal Clinical Study to Evaluate the Safety and ... This study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/p180025b.pdf

summary of safety and effectiveness data (ssed) The PG for the primary effectiveness endpoint was based on published data from the use of suture-mediated closure devices or surgery for access site closure in ...

8. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1585522/full

Comparison of safety and efficacy in venous access ... Conclusion: Large caliber venous access closure with DPSS technique was feasible, safe, and effective to achieve haemostasis after MitraClip ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S155383892500048X

Safety and efficacy of the unilateral, suture-based, dry- ... The procedure became more streamlined with 100% use of local anesthesia, 76% use of left-sided transaxillary access and 87% technical success. •. Improved ...