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Scores range from 0 to 100, with higher scores showing better health status and lower scores showing worsen health status.",{"measure":36,"description":37,"timeFrame":24},"Assess CCM's effect cardiovascular reverse remodeling","Change in LVEF, LVESV, LVEDV from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.",{"measure":39,"description":40,"timeFrame":16},"Assess CCM's effect QRS duration","Change in QRS duration from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.",{"measure":42,"description":43,"timeFrame":16},"Assess CCM's systemic effects","Change in eGFR and BNP from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.",{"measure":45,"description":46,"timeFrame":16},"Assess long-term CCM device-related adverse events and lead related events","An assessment of the incidence of CCM device-related serious complications and non-serious CCM-device-related observations occurring during the 5-year period following the index procedure.",{"measure":48,"description":49,"timeFrame":24},"Assess the dose response of CCM therapy","Correlation of CCM % and milliamp (mA) delivered with clinical outcomes and health status",{"measure":51,"description":52,"timeFrame":24},"Evaluate subject battery charging compliance","Assess overall battery charging compliance defined as 60 minutes of charging per 10-day period between charging sessions (Expressed as percentage of compliant charging periods per subject over time e.g., number of compliant charging cycles ÷ total expected cycles × 100%).",{"measure":54,"description":55,"timeFrame":16},"Assess the effect of ancillary equipment on clinical outcomes","Impact of ancillary equipment on clinical outcomes at 1- 2-, 3-, 4-, and 5-years following the index procedure. Including but not limited to:\n\nLead type: style-driven lead, lumenless lead\n\nGuiding sheath\u002Fcatheter",{"measure":57,"description":58,"timeFrame":16},"Assess CCM clinical outcomes by subject sub-groups","Assess CCM effectiveness at various timepoints in sub-groups of interest, including but not limited to:\n\nMale vs female \\\u003C65 vs ≥ 65-year-old Ischemic vs non-ischemic CRT non-responders Patients with concomitant devices (e.g. CRT, pacemaker, LBBP) Patients with wide, intermediate, narrow QRS Patients with cardiac amyloidosis",null,{"allocation":59,"interventionModel":59,"interventionModelDescription":59,"primaryPurpose":59,"observationalModel":61,"timePerspective":62,"maskingInfo":59},"COHORT","CROSS_SECTIONAL","This is a global, prospective and retrospective, multicenter, single-arm, observational study intended to include patients who will receive\u002Fhave received CCM therapy with an Impulse Dynamics system, including future CCM technologies (e.g. CCM-D), for a follow-up period of at least 5 years.","Patients who will receive\u002Fhave received CCM therapy with an Impulse Dynamics system",[66,69,72],{"label":67,"type":59,"description":68,"interventionNames":59},"Retrospective Cohort","Prospective Cohort",{"label":70,"type":59,"description":71,"interventionNames":59},"Hybrid (Retrospective-Prospective) Cohort","Patients who will receive\u002F have received CCM therapy with an Impulse Dynamics devices",{"label":68,"type":59,"description":73,"interventionNames":59},"Patients who will receive CCM therapy with an Impulse Dynamics devices",[75,78],{"name":76,"affiliation":5,"role":77},"Anthony Hong","STUDY_DIRECTOR",{"name":79,"affiliation":5,"role":77},"Lee Ming Boo",[81,86],{"name":82,"role":83,"phone":84,"phoneExt":59,"email":85},"Karl Van Wygerden","CONTACT","856-642-9933","kvanwygerden@impulsedynamics.com",{"name":87,"role":83,"phone":88,"phoneExt":59,"email":89},"Erika 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Phoenix","NOT_YET_RECRUITING","Phoenix","85006",{"type":100,"coordinates":119},[120,121],-112.07404,33.44838,{"lat":121,"lon":120},[124,128,132,134],{"name":125,"role":83,"phone":126,"phoneExt":59,"email":127},"Sydney Mintalar","612-408-3573","smintalar@arizona.edu",{"name":129,"role":83,"phone":130,"phoneExt":59,"email":131},"Abisola Akinbobola","706-308-5892","abisola.akinbobola@bannerhealth.com",{"name":133,"role":112,"phone":59,"phoneExt":59,"email":59},"Preeneth Katrapati, MD",{"name":135,"role":136,"phone":59,"phoneExt":59,"email":59},"Marc Silver, MD","SUB_INVESTIGATOR",{"facility":138,"status":115,"city":116,"state":95,"zip":139,"country":97,"countryCode":98,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"HonorHealth Research Institute","85020",{"type":100,"coordinates":141},[120,121],{"lat":121,"lon":120},[144,148],{"name":145,"role":83,"phone":146,"phoneExt":59,"email":147},"Kevin 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MD",{"facility":232,"status":93,"city":233,"state":234,"zip":235,"country":97,"countryCode":98,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Massachusetts General Hospital","Boston","Massachusetts","02144",{"type":100,"coordinates":237},[238,239],-71.05977,42.35843,{"lat":239,"lon":238},[242,246,250,252,254,256,258,260,262,264],{"name":243,"role":83,"phone":244,"phoneExt":59,"email":245},"Payton Black","617-643-1972","pblack3@mgh.harvard.edu",{"name":247,"role":83,"phone":248,"phoneExt":59,"email":249},"Chris Azzam","617-643-9621","cazzam@mgh.harvard.edu",{"name":251,"role":112,"phone":59,"phoneExt":59,"email":59},"Theofanie Mela, MD",{"name":253,"role":136,"phone":59,"phoneExt":59,"email":59},"Jagmeet Singh, MD",{"name":255,"role":136,"phone":59,"phoneExt":59,"email":59},"Dingxin Qin, MD",{"name":257,"role":136,"phone":59,"phoneExt":59,"email":59},"Aneesh Bapat, MD",{"name":259,"role":136,"phone":59,"phoneExt":59,"email":59},"Bill Hucker, MD",{"name":261,"role":136,"phone":59,"phoneExt":59,"email":59},"Kevin Heist, MD",{"name":263,"role":136,"phone":59,"phoneExt":59,"email":59},"A Abdul, MD",{"name":265,"role":136,"phone":59,"phoneExt":59,"email":59},"Eric Mills, MD",{"facility":267,"status":115,"city":268,"state":269,"zip":270,"country":97,"countryCode":98,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"University of Michigan","Ann Arbor","Michigan","48109",{"type":100,"coordinates":272},[273,274],-83.74088,42.27756,{"lat":274,"lon":273},[277,279,281],{"name":278,"role":112,"phone":59,"phoneExt":59,"email":59},"Mamid Ghanbari, MD",{"name":280,"role":136,"phone":59,"phoneExt":59,"email":59},"Kirsta Bray, MD",{"name":282,"role":136,"phone":59,"phoneExt":59,"email":59},"Ian Pizzo, MD",{"facility":284,"status":115,"city":285,"state":269,"zip":286,"country":97,"countryCode":98,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"Henry Ford Providence Hospital","Novi","48374",{"type":100,"coordinates":288},[289,290],-83.47549,42.48059,{"lat":290,"lon":289},[293,297],{"name":294,"role":83,"phone":295,"phoneExt":59,"email":296},"Candice Edillo","248-849-3197","cedillo1@hfhs.org",{"name":298,"role":112,"phone":59,"phoneExt":59,"email":59},"Nathan Foster, MD",{"facility":300,"status":115,"city":301,"state":269,"zip":302,"country":97,"countryCode":98,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"Trinity Ann Arbor d\u002Fb\u002Fa Michigan Heart Ann Arbor","Ypsilanti","48197",{"type":100,"coordinates":304},[305,306],-83.61299,42.24115,{"lat":306,"lon":305},[309,313],{"name":310,"role":83,"phone":311,"phoneExt":59,"email":312},"Autumn Howe","734-712-8387","ahowe@michiganheart.com",{"name":314,"role":112,"phone":59,"phoneExt":59,"email":59},"Jihn Han, MD",{"facility":316,"status":115,"city":317,"state":318,"zip":319,"country":97,"countryCode":98,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Minneapolis Heart Institute Research Foundation","Minneapolis","Minnesota","55407",{"type":100,"coordinates":321},[322,323],-93.26384,44.97997,{"lat":323,"lon":322},[326,329],{"name":327,"role":83,"phone":59,"phoneExt":59,"email":328},"Jilianne Feola","julianne.feola@allina.com",{"name":330,"role":112,"phone":59,"phoneExt":59,"email":59},"Jay Sengupta, MD",{"facility":332,"status":115,"city":212,"state":333,"zip":334,"country":97,"countryCode":98,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"Saint Luke's Hospital Mid America Heart Institute","Missouri","64111",{"type":100,"coordinates":336},[337,338],-94.57857,39.09973,{"lat":338,"lon":337},[341,345,349],{"name":342,"role":83,"phone":343,"phoneExt":59,"email":344},"Caroline Murray","816-932-2057","ckempter@saint-lukes.org",{"name":346,"role":83,"phone":347,"phoneExt":59,"email":348},"Sarah Waschow","816-932-9811","swaschow@saint-lukes.org",{"name":350,"role":112,"phone":59,"phoneExt":59,"email":59},"Daniel Steinhaus, MD",{"facility":352,"status":115,"city":212,"state":333,"zip":334,"country":97,"countryCode":98,"cosmosGeoPoint":353,"geoPoint":355,"contacts":356},"Saint Luke's Hospital of Kansas City",{"type":100,"coordinates":354},[337,338],{"lat":338,"lon":337},[357,361,365,367,368,370],{"name":358,"role":83,"phone":359,"phoneExt":59,"email":360},"Kendra Black","816-932-0394","ktraylor@saint-lukes.org",{"name":362,"role":83,"phone":363,"phoneExt":59,"email":364},"Amada Huffman","816-932-0391","ahuffman@saint-lukes.org",{"name":366,"role":112,"phone":59,"phoneExt":59,"email":59},"Timothy Fendler, MD",{"name":350,"role":136,"phone":59,"phoneExt":59,"email":59},{"name":369,"role":136,"phone":59,"phoneExt":59,"email":59},"Sanjaya Gupta, MD",{"name":371,"role":136,"phone":59,"phoneExt":59,"email":59},"Jose Aguilera, MD",{"facility":373,"status":115,"city":374,"state":375,"zip":376,"country":97,"countryCode":98,"cosmosGeoPoint":377,"geoPoint":381,"contacts":382},"Cardiovascular Specialists of New England Research Foundation","Londonderry","New Hampshire","03053",{"type":100,"coordinates":378},[379,380],-71.37395,42.86509,{"lat":380,"lon":379},[383,387,389,391,393],{"name":384,"role":83,"phone":385,"phoneExt":59,"email":386},"Jennifer Driscoll","603-323-0883","jennifer.driscoll@csofne.com",{"name":388,"role":112,"phone":59,"phoneExt":59,"email":59},"David Chang, MD",{"name":390,"role":136,"phone":59,"phoneExt":59,"email":59},"Jamie Kim, MD",{"name":392,"role":136,"phone":59,"phoneExt":59,"email":59},"Jinu John, MD",{"name":394,"role":136,"phone":59,"phoneExt":59,"email":59},"Jeanney Lew, MD",{"facility":396,"status":115,"city":397,"state":398,"zip":399,"country":97,"countryCode":98,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"Deborah Heart and Lung Center","Browns Mills","New Jersey","08015",{"type":100,"coordinates":401},[402,403],-74.58293,39.97261,{"lat":403,"lon":402},[406,411,415,417,419],{"name":407,"role":83,"phone":408,"phoneExt":409,"email":410},"Lout Lewis","609-893-1200","5022","LewisL@Deborah.org",{"name":412,"role":83,"phone":408,"phoneExt":413,"email":414},"Andrew McElvarr","5016","Mcelavarra@deborah.org",{"name":416,"role":112,"phone":59,"phoneExt":59,"email":59},"Raffaele Corbisiero, MD",{"name":418,"role":136,"phone":59,"phoneExt":59,"email":59},"G Rojas-Marte, MD",{"name":420,"role":136,"phone":59,"phoneExt":59,"email":59},"J Krathen, DO",{"facility":422,"status":115,"city":423,"state":398,"zip":424,"country":97,"countryCode":98,"cosmosGeoPoint":425,"geoPoint":429,"contacts":430},"Hackensack University Medical Center","Hackensack","07601",{"type":100,"coordinates":426},[427,428],-74.04347,40.88593,{"lat":428,"lon":427},[431,435,438],{"name":432,"role":83,"phone":433,"phoneExt":59,"email":434},"Manuel Castillo","551-996-4451","manuel.castillo@hmhn.org",{"name":436,"role":83,"phone":433,"phoneExt":59,"email":437},"Brandon Palmer","brandon.palmer@hmhn.org",{"name":439,"role":112,"phone":59,"phoneExt":59,"email":59},"Sameer Jamal, MD",{"facility":441,"status":115,"city":442,"state":398,"zip":443,"country":97,"countryCode":98,"cosmosGeoPoint":444,"geoPoint":448,"contacts":449},"Rutgers New Jersey Medical School & University Hospital","Newark","07103",{"type":100,"coordinates":445},[446,447],-74.17237,40.73566,{"lat":447,"lon":446},[450,454,457,459,461],{"name":451,"role":83,"phone":452,"phoneExt":59,"email":453},"Adel Aly","973-972-1054","aaa531@njms.rutgers.edu",{"name":455,"role":83,"phone":59,"phoneExt":59,"email":456},"Hector Salcedo","hrs60@njms.rutgers.edu",{"name":458,"role":112,"phone":59,"phoneExt":59,"email":59},"Amed Aziz, MD",{"name":460,"role":136,"phone":59,"phoneExt":59,"email":59},"Pallavi Solanski, MD",{"name":462,"role":136,"phone":59,"phoneExt":59,"email":59},"Luka Petrovic, MD",{"facility":464,"status":115,"city":465,"state":466,"zip":467,"country":97,"countryCode":98,"cosmosGeoPoint":468,"geoPoint":472,"contacts":473},"Providence St. Vincent Medical Center","Portland","Oregon","97225",{"type":100,"coordinates":469},[470,471],-122.67621,45.52345,{"lat":471,"lon":470},[474,478,482,484],{"name":475,"role":83,"phone":476,"phoneExt":59,"email":477},"Sarah Jackson","503-216-7370","Sarah.Jackson3@providence.org",{"name":479,"role":83,"phone":480,"phoneExt":59,"email":481},"Marcia Macsisak","503-216-7195","Marcia.Macsisak@providence.org",{"name":483,"role":112,"phone":59,"phoneExt":59,"email":59},"Joshua Remick, MD",{"name":485,"role":136,"phone":59,"phoneExt":59,"email":59},"Alexi Zemsky, MD",{"facility":487,"status":115,"city":465,"state":466,"zip":488,"country":97,"countryCode":98,"cosmosGeoPoint":489,"geoPoint":491,"contacts":492},"Legacy Medical Group Cardiology","98686",{"type":100,"coordinates":490},[470,471],{"lat":471,"lon":470},[493,497,499],{"name":494,"role":83,"phone":495,"phoneExt":59,"email":496},"Kristin Hickey","503-413-4365","khickey@lhs.org",{"name":498,"role":112,"phone":59,"phoneExt":59,"email":59},"Brendan Daly, 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Lukes","Milwaukee","Wisconsin","53215",{"type":100,"coordinates":640},[641,642],-87.90647,43.0389,{"lat":642,"lon":641},[645,649],{"name":646,"role":83,"phone":647,"phoneExt":59,"email":648},"Rebecca Hough","262-248-5430","rebecca.hough@aah.org",{"name":650,"role":112,"phone":59,"phoneExt":59,"email":59},"Imran Niazi, MD",{"type":652,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","100601625",false,"NCT07112924","CCM OPEN HF Registry","CCM Technologies OPEN HF Registry: Observational Patient EvaluatioN of CCM® Therapy for Heart Failure","CCM OPEN HF","Inclusion Criteria:\n\n* Patients who have \u002Fwill be implanted with Impulse Dynamics CCM technologies (e.g. CCM or CCM-D when available) as determined by investigators\n* Willing and able to provide informed consent, including for use of data for research purposes (e.g. publication, sub-studies\u002Fsub-analyses)\n\nExclusion Criteria:\n\n* Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators.\n* Subjects with a mechanical tricuspid valve","ALL","18 Years",{"count":663,"type":664},5500,"ESTIMATED","OBSERVATIONAL","The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.",[668],"Heart Failure",[668,670,671,672,673,674,675,676,677,678,679],"CCM","Optimizer","Implantable Pulse Generator","FDA Approved","Heart Failure Hospitalization","Ischemic vs non-ischemic","CRT non-responders","Patients with concomitant devices","Patients with wide, intermediate, narrow QRS","Patients with cardiac amyloidosis","2026-04-20",{"date":682,"type":683},"2026-04-23","ACTUAL",{"date":685,"type":683},"2025-11-01",{"date":687,"type":664},"2036-08-01",{"name":5,"class":6},28]