protocolSection identificationModule nctId: NCT06378632, orgStudyIdInfo id: CLN0011 DETECT-HF, briefTitle: AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM, acronym: DETECT-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-11, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Cordio Medical, class: INDUSTRY, descriptionModule briefSummary: Study Design:This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Hearo App, outcomesModule primaryOutcomes measure: Heart Failure Events (HFEs), eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eastern Shore Research Institute, status: RECRUITING, city: Fairhope, state: Alabama, zip: 36532, country: United States, contacts name: Jessica Huckleberry, SC, role: CONTACT, phone: 251-990-1920, email: jessicahuckleberry@yahoo.com, contacts name: Michael Pursley, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.52297, lon: -87.90333, locations facility: UC San Diego Health, status: RECRUITING, city: La Jolla, state: California, zip: 92037, country: United States, contacts name: Joshua Gillman, SC, role: CONTACT, phone: 858-246-2511, email: j1gillman@health.ucsd.edu, contacts name: Nicholas Wettersten, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: VA Loma Linda Healthcare System, status: RECRUITING, city: Loma Linda, state: California, zip: 92357, country: United States, contacts name: Vicki Simpson, SC, role: CONTACT, phone: 909-593-6361, email: vicki.simpson@va.gov, contacts name: Jay Patel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.04835, lon: -117.26115, locations facility: VA San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92161, country: United States, contacts name: Jonathan Narita, SC, role: CONTACT, phone: 858-642-3512, email: jonathan.narita@va.gov, contacts name: Nancy Gardetto, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: University of California, San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94117, country: United States, contacts name: Priscilla Zhang, SC, role: CONTACT, phone: 415-514-7903, email: priscilla.zhang@ucsf.edu, contacts name: Liviu Klein, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Kaiser Permanente San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94118, country: United States, contacts name: Priscilla Chung, SC, role: CONTACT, phone: 415-833-3480, email: priscilla.s.chung@kp.org, contacts name: Jana Svetlichanaya, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Nature Coast Clinical Research, status: RECRUITING, city: Crystal River, state: Florida, zip: 34429, country: United States, contacts name: Nina Smith, SC, role: CONTACT, phone: 352-563-1865, email: nsmith@encoredocs.com, contacts name: Susan Pasupuleti, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.90248, lon: -82.5926, locations facility: Jacksonville Center for Clinical Research, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32216, country: United States, contacts name: Taylor Johnson, SC, role: CONTACT, phone: 904-730-0101, email: tjohnson@encoredocs.com, contacts name: Michael Koren, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Amavita Clinical Research, status: RECRUITING, city: Miami, state: Florida, zip: 33137, country: United States, contacts name: Nereisy Alonso, SC, role: CONTACT, phone: 786-703-5941, email: researchadmin@amavita.health, contacts name: Pedro Martinez Clark, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Advance Medical Research Services Corp (AMRS), status: RECRUITING, city: Miami, state: Florida, zip: 33173, country: United States, contacts name: Adam Rachid, SC, role: CONTACT, phone: 305-928-8845, email: arachid.amrs@gmail.com, contacts name: Yordan Orive Gomez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Baptist Health (Miami Cardiac & Vascular Institute), status: RECRUITING, city: Miami, state: Florida, zip: 33173, country: United States, contacts name: Margie Mckercher, SC, role: CONTACT, phone: 786-595-8075, email: margie.mchercher@baptisthealth.net, contacts name: Sandra Chaparro, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Comprehensive Medical & Research Center, status: RECRUITING, city: Plantation, state: Florida, zip: 33317, country: United States, contacts name: Wilmer Santiesteban Garcia, SC, role: CONTACT, phone: 954-368-3529, email: wsantiesteban@compmedical.net, contacts name: William Korey, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.13421, lon: -80.23184, locations facility: St. Johns Center for Clinical Research, status: RECRUITING, city: Saint Augustine, state: Florida, zip: 32086, country: United States, contacts name: Valerie Hayes, SC, role: CONTACT, phone: 904-209-0043, email: vhayes@encoredocs.com, contacts name: Ameeth Vedre, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.89469, lon: -81.31452, locations facility: Tampa General Hospital, status: RECRUITING, city: Tampa, state: Florida, zip: 33606, country: United States, contacts name: Kiria Almeida-Tamayo, SC, role: CONTACT, phone: 813-844-8058, email: kalmeidatamayo@tgh.org, contacts name: Debbie Hoffman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, locations facility: West Georgia Cardiology, status: RECRUITING, city: Carrollton, state: Georgia, zip: 30117, country: United States, contacts name: Justina Okeke, SC, role: CONTACT, phone: 678-839-7285, email: justina.okeke@westgacardiology.com, contacts name: Charlie Rouse, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.58011, lon: -85.07661, locations facility: University of Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Veronica Herzog, SC, role: CONTACT, phone: 773-834-9794, email: vherzog@bsd.uchicago.edu, contacts name: Gene Kim, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Advocate Illinois Masonic Medical Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60657, country: United States, contacts name: Maci Eiber, SC, role: CONTACT, phone: 773-296-0969, email: maci.eiber@aah.org, contacts name: Sorin Danciu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Advocate Illinois Masonic Health Center, status: RECRUITING, city: Downers Grove, state: Illinois, zip: 60515, country: United States, contacts name: Debra Heidenreich, SC, role: CONTACT, phone: 630-352-2338, email: debra.heidenreich@aah.org, contacts name: Sorin Danciu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.80892, lon: -88.01117, locations facility: Midwest Cardiovascular Center, status: RECRUITING, city: Naperville, state: Illinois, zip: 60540, country: United States, contacts name: Josilyn Klimek, SC, role: CONTACT, phone: 630-600-0730, email: josilyn.klimek@cardio.com, contacts name: Maria Rosa Costanzo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.78586, lon: -88.14729, locations facility: Robert J. Dole VA Medical Center, status: RECRUITING, city: Wichita, state: Kansas, zip: 67218, country: United States, contacts name: Deborah Garner, sc, role: CONTACT, phone: 316-685-2221, phoneExt: 53352, email: deborah.garner@va.gov, contacts name: Freidy Eid, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.69224, lon: -97.33754, locations facility: St. Elizabeth Healthcare, status: RECRUITING, city: Edgewood, state: Kentucky, zip: 41017, country: United States, contacts name: Cynthia Mulcahy, SC, role: CONTACT, phone: 859-301-4046, email: cynthia.mulcahy@stelizabeth.com, contacts name: Haree Vongooru, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.01867, lon: -84.58189, locations facility: Cardiovascular Institute of the South, status: RECRUITING, city: Houma, state: Louisiana, zip: 70360, country: United States, contacts name: Kimberly Lirette, SC, role: CONTACT, phone: 985-873-5619, email: kimberly.lirette@cardio.com, contacts name: Peter Fail, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.59577, lon: -90.71953, locations facility: Cardiovascular Institute of the South, status: RECRUITING, city: Lafayette, state: Louisiana, zip: 70503, country: United States, contacts name: June Jones, SC, role: CONTACT, phone: 337-289-8429, email: june.jones@cardio.com, contacts name: Wade May, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.22409, lon: -92.01984, locations facility: University Medical Center New Orleans, status: RECRUITING, city: New Orleans, state: Louisiana, zip: 70112, country: United States, contacts name: Katasha Washington, SC, role: CONTACT, phone: 504-702-4704, email: katasha.washington@lcmchealth.org, contacts name: Frank Smart, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Nebraska Heart Center, status: RECRUITING, city: Lincoln, state: Nebraska, zip: 68526, country: United States, contacts name: Julie Potter, SC, role: CONTACT, phone: 402-328-3950, email: julie.potter@commonspirit.org, contacts name: Steven Krueger, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.8, lon: -96.66696, locations facility: VA Southern Nevada Healthcare System, status: RECRUITING, city: North Las Vegas, state: Nevada, zip: 89086, country: United States, contacts name: Rosalinda Cruz, SC, role: CONTACT, phone: 702-791-9000, phoneExt: 15575, email: Rosalinda.cruz@va.gov, contacts name: Marriyam Moten, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.19886, lon: -115.1175, locations facility: Mount Sinai Morningside, status: RECRUITING, city: New York, state: New York, zip: 10025, country: United States, contacts name: Kathy Idrissi, SC, role: CONTACT, phone: 646-561-1170, email: katharine.idrissi2@mountsinai.org, contacts name: Kiran Mahmood, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: The Mount Sinai Hospital, status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Lovelyne Julien, SC, role: CONTACT, phone: 212-241-1537, email: lovelyne.julien@mountsinai.org, contacts name: Anuradha Lala - Trindade, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: St. Francis Hospital, status: RECRUITING, city: Roslyn, state: New York, zip: 11576, country: United States, contacts name: Lyn Santiago, SC, role: CONTACT, phone: 516-562-6763, email: lyn.santiago@chsli.org, contacts name: Rita Jermyn, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.79982, lon: -73.65096, locations facility: Mission Hospital, status: RECRUITING, city: Asheville, state: North Carolina, zip: 28803, country: United States, contacts name: Josephine Purbrick, SC, role: CONTACT, phone: 828-412-9149, email: josephine.purbrick@sarahcannon.com, contacts name: Vinay Thohan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.60095, lon: -82.55402, locations facility: Moses H. Cone Memorial Hospital, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27401, country: United States, contacts name: Michelle McCart, SC, role: CONTACT, phone: 336-832-3799, email: michelle.mccart@conehealth.com, contacts name: Daniel Bensimhon, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, locations facility: The Lindner Research Center at The Christ Hospital, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45219, country: United States, contacts name: Kathryn Gloria, SC, role: CONTACT, email: katherineaubre.glori@thechristhospital.com, contacts name: Eugene Chung, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Savi Radesic, role: CONTACT, phone: 216-445-6916, email: radesis@ccf.org, contacts name: W.H. Wilson Tang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, locations facility: The Ohio State University, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Carina Pannelle, role: CONTACT, phone: 614-366-8650, email: carina.panelle@osumc.edu, contacts name: Rami Kahwash, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Vanderbilt University Medical Center, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Terry Weyand, SC, role: CONTACT, phone: 615-322-9349, email: terry.l.weyand@vumc.org, contacts name: JoAnn Lindenfeld, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Rio Grande Regional Hospital, status: RECRUITING, city: McAllen, state: Texas, zip: 78503, country: United States, contacts name: Dina Garcia, SC, role: CONTACT, phone: 956-632-6054, email: dina.garcia2@hcahealthcare.com, contacts name: Norman Ramirez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.20341, lon: -98.23001, locations facility: Methodist Hospital of San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Maurene Cantu, role: CONTACT, phone: 210-218-4950, email: maurene.cantu@hcahealthcare.com, contacts name: Sachin Gupta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: University Hospital Samson Assuta Ashdod, status: RECRUITING, city: Ashdod, country: Israel, contacts name: Sapir Swisa, SC, role: CONTACT, contacts name: Alexander Goldman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.79211, lon: 34.64967, locations facility: Assuta Be'er Sheva Medical Center, status: RECRUITING, city: Be'er Sheva, country: Israel, contacts name: Alex Demitriev, SC, role: CONTACT, contacts name: Amos Katz, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.25181, lon: 34.7913, locations facility: Rambam Medical Center, status: RECRUITING, city: Haifa, country: Israel, contacts name: Ludmila Helmer, SC, role: CONTACT, phone: 972-4-7773475, contacts name: Oren Caspi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.81841, lon: 34.9885, locations facility: Shaare Zedek Medical Center, status: RECRUITING, city: Jerusalem, country: Israel, contacts name: Hadas Barda, SC, role: CONTACT, phone: 972-2-6666769, contacts name: Tal Hasin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Galiee Medical Center, status: RECRUITING, city: Nahariya, country: Israel, contacts name: Etti Lasri Kadosh, SC, role: CONTACT, phone: 972-4-9107747, contacts name: Shaul Atar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.00892, lon: 35.09814, locations facility: Tel Aviv Sourasky (Ichilov) Medical Center, status: RECRUITING, city: Tel Aviv, country: Israel, contacts name: Tal Fux, SC, role: CONTACT, phone: 972-3-6972420, contacts name: Michal Laufer Perl, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08088, lon: 34.78057, locations facility: Poriya Medical Center, status: RECRUITING, city: Tiberias, country: Israel, contacts name: Jannat Mukari, SC, role: CONTACT, phone: 972-4-6652201, contacts name: Wadi Kinany, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.79221, lon: 35.53124, hasResults: False