[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606301":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":28,"enrollmentInfo":74,"targetDuration":28,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":90,"whyStopped":28,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Boston Medical Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A","EXPERIMENTAL","Cardiac patients who are undergoing interventional cardiac procedure including electrophysiology (EP) with planned retrograde left ventricular access or diagnostic coronary catheterization.",[13],"Device: Cardiac Waveform Generator",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B","Patients who have pacing indication and are undergoing routine generator exchange of dual chamber cardiac implantable electronic device (CIED).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort C","Patients who are undergoing new implant or generator exchange of CIED with cardiac resynchronization therapy.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Cardiac Waveform Generator","A pacing device that allows for programmable pulse waveforms to generate a predefined set of anodal biphasic waveforms. It possesses a battery-powered floating point gate array (FPGA) using software that allows flexibility in waveform configuration.",[9,15,19],null,[30],{"name":31,"affiliation":32,"role":33},"Robert Helm, MD","Boston Medical Center, Cardiology","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":28,"email":38},"CONTACT","617-638-8985","robert.helm@bmc.org",{"name":40,"role":36,"phone":41,"phoneExt":28,"email":42},"Denise Fine, BS","617-638-8716","denise.fine@bmc.org",[44],{"facility":5,"status":28,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Boston","Massachusetts","02118","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.05977,42.35843,{"lat":54,"lon":53},[57,58],{"name":31,"role":36,"phone":28,"phoneExt":28,"email":38},{"name":40,"role":36,"phone":28,"phoneExt":28,"email":42},{"type":60,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[62],{"name":63,"class":64},"Rocky Mountain Biphasic","UNKNOWN","100606301","cardiac-anodal-biphasic-pacing-100606301",false,"NCT07173777","Cardiac Anodal Biphasic Pacing","ABP","Inclusion Criteria:\n\nCohort A\n\n• Planned interventional cardiac procedure\n\nCohort B\n\n* Planned generator exchange of dual chamber cardiac implantable electronic device (CIED)\n* Functioning atrial lead\n\nCohort C\n\n* Planned de novo implant or generator exchange of CIED with cardiac resynchronization therapy\n* Functioning atrial lead\n\nExclusion Criteria:\n\n* Permanent atrial fibrillation\n* Third degree AV block without stable escape rhythm\n* Ischemic heart disease or coronary disease \\> 40%\n* Unable to receive heparin\n* Are not fluent in English\n* Unable to read in English\n* Not able to provide informed consent\n* Women who are pregnant","ALL","18 Years",{"count":75,"type":76},108,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this study is to test a new pacing method called anodal biphasic pacing (ABP) to determine if this pacing works as well-or better-than current pacing methods. This new method may improve how the heart works and reduce some of the problems caused by regular pacing.\n\nCurrent implantable pacemakers use a monophasic cathodal waveform to stimulate the heart. Monophasic cathodal pacing (MCP) waveforms slow conduction, impair contractility, cause inflammation, increase risk of atrial fibrillation, heart failure, and mortality. Anodal biphasic pacing (ABP) is an alternative waveform that can stimulate the heart. ABP preconditions the heart and then initiates cardiac contraction. ABP may address the limitations of MCP.",[82],"Cardiac Pacing",[84,85,86,87,88,89],"Anodal biphasic pacing (ABP)","Monophasic cathodal pacing (MCP)","Ejection fraction","Cardiac implantable electronic device","Cardiac contractility modulation","Implantable cardiac defibrillator","NOT_YET_RECRUITING","2026-04-27",{"date":93,"type":94},"2026-04-28","ACTUAL",{"date":96,"type":76},"2026-07",{"date":98,"type":76},"2027-07",{"name":5,"class":6},1]