[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03604133":3,"trial-entities:NCT03604133":71,"trial-summary:NCT03604133":74},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":26,"secondary_outcomes":31,"sex":32,"minimum_age":16,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":33,"std_ages":39,"locations":43,"central_contacts":59,"overall_officials":68,"references":69,"see_also_links":70},"NCT03604133","2018-310 Cardiac Registry","Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry","RECRUITING","2028-08-24","2021-01","2021-01-22","2017-08-24","QuesGen Systems Inc","OTHER",false,"The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check.",null,[18],"Arrhythmia",[],"OBSERVATIONAL",[],{"count":23,"type":24},500,"ESTIMATED",[],[27],{"measure":28,"description":29,"timeFrame":30},"Successful Implantation","Patient undergoes surgery for ICD device implantation","Two-week follow-up assessment",[],"ALL",{"inclusion":34,"exclusion":36,"raw_text":38},[35],"Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)",[37],"N\u002FA","Inclusion Criteria:\n\n* Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)\n\nExclusion Criteria:\n\n* N\u002FA",[40,41,42],"CHILD","ADULT","OLDER_ADULT",[44],{"facility":45,"status":7,"city":46,"state":47,"zip":48,"country":49,"contacts":50,"geoPoint":56},"Cardio Surgical Partners, LLC","Lehi","Utah","84043","United States",[51],{"name":52,"role":53,"phone":54,"email":55},"Michael Dutton","CONTACT","801-358-4231","mdutton@cardiosp.com",{"lat":57,"lon":58},40.39162,-111.85077,[60,64],{"name":61,"role":53,"phone":62,"email":63},"Michael Jarrett, MBA","415-608-3570","mike.jarrett@quesgen.com",{"name":65,"role":53,"phone":66,"email":67},"Martin Jorgensen, PhD","650-777-7617","martin.jorgensen@quesgen.com",[],[],[],{"nct_id":4,"conditions":72,"biomarkers":73},[18],[],{"nct_id":4,"found":75,"summary":76,"prompt_version":86},true,{"design":77,"status":78,"heading":79,"summary":80,"follow_up":81,"word_count":82,"commitments":83,"compensation":84,"drugs_mentioned":85},"This is an observational study, meaning researchers will collect information about patients who are already receiving care, rather than assigning treatments. It aims to enroll 500 participants.","completed","Observational Study of Implantable Cardioverter-Defibrillators in Ambulatory Surgical Centers","This is an observational study looking at the outcomes of patients who receive an implantable cardioverter-defibrillator (ICD) in an Ambulatory Surgical Center (ASC). An ICD is a small device placed in your chest or abdomen that helps regulate your heartbeat if you have an arrhythmia (irregular heartbeat). This study aims to understand how often serious problems or side effects occur with these devices, and to see if having the procedure in an ASC is efficient for both patients and doctors in terms of cost and time. You may be able to join if your doctor recommends you receive an ICD in an ASC. The study will consider the implantation successful if there are no serious complications or adverse events at a two-week follow-up.","Participants will be followed for two weeks after the implant for a wound check.",123,"You would have data collected at the time of screening, during the implant procedure, and at a wound check two weeks after the implant.","Not stated in the trial record.",[],"v2"]