Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: percutaneous suture mediated closure, Figure of Eight Suture.
- Who it may be relevant to
- Registry conditions: Vascular Closure, Pacemaker Implantation, Leadless Pacemaker. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Comparison of Percutaneous Closure to a Figure-of-eight Suture With Manual Compression for Hemostasis of Large-bore Access for Leadless Pacemaker Implantation
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.
Interventions
- Device percutaneous suture mediated closure
Vascular closure with a commercially available SMC device. - Device Figure of Eight Suture
Manual Compression with Figure of Eight Suture (control).
Primary outcome measures
- Time to Hemostasis [Time frame: During the procedure.]
Secondary outcome measures (5)
- Time to discharge eligibility [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 [Time frame: 0 and 30 days]
- Minor access related complications [Time frame: 0 and 30 days]
- Patient reported outcomes [Time frame: 0 and 30 days]
- Costs [Time frame: 0 and 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UMass Chan Medical School — Worcester
Identifiers
NCT: NCT06837870 · STUDY00002172