[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06837870":3,"trial-entities:NCT06837870":102,"trial-summary:NCT06837870":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":50,"secondary_outcomes":55,"sex":72,"minimum_age":73,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":85,"locations":88,"central_contacts":98,"overall_officials":99,"references":100,"see_also_links":101},"NCT06837870","STUDY00002172","Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.","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","ENROLLING_BY_INVITATION","2027-01-01","2026-03","2026-03-27","2025-07-11","University of Massachusetts, Worcester","OTHER",false,"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.",null,[19,20,21],"Vascular Closure","Pacemaker Implantation","Leadless Pacemaker",[23,24,25,26],"perclose","percutaneous closure","leadless pacemaker","venous access","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},50,"ESTIMATED",[35,43],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"DEVICE","percutaneous suture mediated closure","Vascular closure with a commercially available SMC device.",[40],"SMC",[42],"PerClose, ProStyle",{"type":36,"name":44,"description":45,"armGroupLabels":46,"otherNames":48},"Figure of Eight Suture","Manual Compression with Figure of Eight Suture (control).",[47],"MC",[49],"Fo8",[51],{"measure":52,"description":53,"timeFrame":54},"Time to Hemostasis","Time from sheath pull to hemostasis.","During the procedure.",[56,60,64,66,69],{"measure":57,"description":58,"timeFrame":59},"Time to discharge eligibility","Time from sheath pull to eligibility for discharge.","Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.",{"measure":61,"description":62,"timeFrame":63},"Major access related complications","Composite and individual access related complications","0 and 30 days",{"measure":65,"description":62,"timeFrame":63},"Minor access related complications",{"measure":67,"description":68,"timeFrame":63},"Patient reported outcomes","Patient reported outcomes of both a pain and satisfaction ascertained by a questionnaire reported as a total\u002Fcomposite score of all questions, as well as the score for each individual question on the questionnaire (rated on a likert scale).",{"measure":70,"description":71,"timeFrame":63},"Costs","Direct and indirect procedure and peri-procedural cost data","ALL","18 Years",{"inclusion":75,"exclusion":79,"raw_text":84},[76,77,78],"Patients aged 18 and older","Patients undergoing leadless pacemaker implant at UMass Chan Medical Center","Subjects able to understand and provide written informed consent.",[80,81,82,83],"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.","Inclusion Criteria:\n\n* Patients aged 18 and older\n* Patients undergoing leadless pacemaker implant at UMass Chan Medical Center\n* Subjects able to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patents who are not able to ambulate prior to the procedure\n* 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\n* Prisoners or wards of the state.",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"geoPoint":95},"UMass Chan Medical School","Worcester","Massachusetts","01655","United States",{"lat":96,"lon":97},42.26259,-71.80229,[],[],[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Leadless Pacemaker Implantation",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]