Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-31 @ 2:53 AM
Study NCT ID:
NCT04331769
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2020-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2020-03-30', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes from baseline in mitral effective regurgitant orifice area (EROA)', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 730 days'}, {'measure': 'Changes from baseline in left atrial strain measured by Echo', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 730 days'}, {'measure': 'Changes from baseline in left ventricular global longitudinal strain measured by Echo', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 730 days'}, {'measure': 'Changes from baseline in right ventricular free wall longitudinal strain measured by Echo', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 730 days'}, {'measure': 'Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days', 'description': 'Higher scores in the KCCQ reflect better health status'}, {'measure': 'Changes from baseline in EuroQol Five Dimension Five Level (EQ-5D-5L) Quality of Life Questionnaire', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days', 'description': 'Lower scores in the EQ-5D-5L reflect better health status'}, {'measure': 'Changes from baseline in right ventricular (RV) fractional area change measured by Echo', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 730 days', 'description': 'Measured by percent change'}, {'measure': 'Changes from baseline in tricuspid annular plane systolic excursion (TAPSE) measured by Echo', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 730 days', 'description': 'Measured in centimeters or millimeters'}, {'measure': 'Changes from baseline in tricuspid regurgitation measured by Echo', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 730 days', 'description': 'Measured using effective regurgitant orifice area (mm2) and regurgitant volume (mL)'}], 'primaryOutcomes': [{'measure': 'Freedom from device- or femoral artery access-related major adverse events (MAE)', 'timeFrame': '180 days', 'description': 'MAE defined as:\n\n1. All-cause death,\n2. Myocardial infarction,\n3. Stroke,\n4. Need for non-elective cardiovascular surgery,\n5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours\n6. Acute kidney injury requiring renal replacement therapy'}, {'measure': 'Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score', 'timeFrame': '180 days', 'description': 'Higher scores in the KCCQ reflect better health status'}, {'measure': '6-Minute Walk Test (6MWT) distance (m)', 'timeFrame': '180 days', 'description': 'Change in 6MWT distance (m) from baseline'}, {'measure': 'Freedom from device- or femoral artery access-related major adverse events (MAE)', 'timeFrame': '365 days', 'description': 'MAE defined as:\n\n1. All-cause death,\n2. Myocardial infarction,\n3. Stroke,\n4. Need for non-elective cardiovascular surgery,\n5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours\n6. Acute kidney injury requiring renal replacement therapy'}, {'measure': 'A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)', 'timeFrame': '365 days', 'description': 'A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method'}], 'secondaryOutcomes': [{'measure': 'Number of all-cause deaths or all-cause hospitalizations', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days'}, {'measure': 'Number of all-cause deaths', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days'}, {'measure': 'Number of all-cause hospitalizations', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days'}, {'measure': 'Incidence of all serious adverse events, including device- and procedure- related complications', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days'}, {'measure': 'Changes from baseline in New York Heart Association (NYHA) functional class', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days'}, {'measure': 'Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)', 'timeFrame': '30 days, 90 days, 365 days, 545 days, 730 days', 'description': 'Higher scores in the KCCQ reflect better health status'}, {'measure': 'Changes from baseline in 6-Minute Walk Test (6MWT)', 'timeFrame': '30 days, 90 days, 365 days, 545 days, 730 days', 'description': 'Measure in meters'}, {'measure': 'Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo', 'timeFrame': '30 days, 90 days, 365 days, 730 days'}, {'measure': 'Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT', 'timeFrame': '180 days'}, {'measure': 'Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo', 'timeFrame': '30 days, 90 days, 365 days, 730 days'}, {'measure': 'Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT', 'timeFrame': '180 days'}, {'measure': 'Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo', 'timeFrame': '30 days, 90 days, 365 days, 730 days'}, {'measure': 'Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT', 'timeFrame': '180 days'}, {'measure': 'Rate and number of cardiovascular death events', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days'}, {'measure': 'Rate and number of heart failure death events', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days'}, {'measure': 'Rate and number of heart failure-related hospitalizations', 'timeFrame': '30 days, 90 days, 180 days, 365 days, 545 days, 730 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Reduced Ejection Fraction', 'Cardiomyopathy'], 'conditions': ['Heart Failure With Reduced Ejection Fraction (HFrEF)', 'Dilated Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '36958391', 'type': 'DERIVED', 'citation': 'Hamid N, Jorde UP, Reisman M, Latib A, Lim DS, Joseph SM, Kurlianskaya A, Polonetsky O, Neuzil P, Reddy V, Foerst J, Gada H, Grubb KJ, Silva G, Kereiakes D, Shreenivas S, Pinney S, Davidavicius G, Sorajja P, Boehmer JP, Kleber FX, Perier P, VAN Mieghem NM, Dumonteil N, Leon MB, Burkhoff D. Transcatheter Left Ventricular Restoration in Patients With Heart Failure. J Card Fail. 2023 Jul;29(7):1046-1055. doi: 10.1016/j.cardfail.2023.03.003. Epub 2023 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).', 'detailedDescription': 'The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System.\n\nSubjects will be randomized in a 1:1 ratio:\n\n1. Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n\\~200)\n2. Control group: Guideline-directed medical therapy (GDMT) (n\\~200)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-years or older\n2. Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab\n3. LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab\n4. Symptom Status:\n\n 1. NYHA III,\n 2. NYHA ambulatory IV, or\n 3. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)\n5. Able to complete six-minute walk test with distance between 100 m and 450 m.\n6. Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented.\n\n 1. "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments\n 2. When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change\n 3. When additional titration is required to optimize a subject\'s medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters)\n 4. When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments\n 5. When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change\n 6. If an SGLT2 inhibitor is added to a subject\'s medications, the screening TTE and CT will be postponed at least 30 days after the addition\n 7. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments\n 8. If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters)\n 9. When applicable, for guideline-directed device-based therapies: a CRT device must be placed \\> 90 days before the screening TTE and CT, and an ICD must be placed \\> 30 days before the screening TTE and CT\n7. Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule\n\nExclusion Criteria:\n\nCardiovascular\n\n1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent\n2. Untreated clinically significant coronary artery disease (CAD) requiring revascularization\n3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation\n4. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan\n5. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)\n6. Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support\n7. Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures)\n8. Active bacterial endocarditis\n9. Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE\n10. Fixed pulmonary hypertension with PA systolic pressure \\>70 mmHg not responsive to vasodilator therapy\n11. History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke\n\n Valvular\n12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)\n13. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)\n14. Prior mitral or aortic valve replacement\n15. Tricuspid regurgitation grade 4+ (severe)\n16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax \\>300 cm/sec)\n17. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe)\n\n Procedural\n18. Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath)\n19. Renal insufficiency (i.e., eGFR of \\<25 ml/min/1.73 m2)\n20. Subjects in whom anticoagulation during the procedure is contraindicated\n21. Subjects in whom 90 days of antiplatelet therapy is contraindicated\n22. Known allergy to nitinol, polyester, or polyethylene\n23. Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure\n\n General\n24. Life expectancy \\<1 year due to non-cardiac conditions\n25. Currently participating in another interventional investigational study\n26. Subjects on high dose steroids or immunosuppressant therapy\n27. Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating'}, 'identificationModule': {'nctId': 'NCT04331769', 'briefTitle': 'Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ancora Heart, Inc.'}, 'officialTitle': 'Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study', 'orgStudyIdInfo': {'id': '5019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device group: AccuCinch Ventricular Restoration System', 'description': 'Subjects in this arm will receive the AccuCinch Ventricular Restoration System', 'interventionNames': ['Device: AccuCinch Ventricular Restoration System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group: Guideline-Directed Medical Therapy', 'description': 'Subjects in this arm will receive guideline-directed medical therapy (GDMT)', 'interventionNames': ['Drug: Guideline-Directed Medical Therapy']}], 'interventions': [{'name': 'AccuCinch Ventricular Restoration System', 'type': 'DEVICE', 'description': 'AccuCinch Ventricular Restoration System', 'armGroupLabels': ['Device group: AccuCinch Ventricular Restoration System']}, {'name': 'Guideline-Directed Medical Therapy', 'type': 'DRUG', 'description': 'Guideline-Directed Medical Therapy', 'armGroupLabels': ['Control group: Guideline-Directed Medical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Grandview Medical Group Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Araceli Lazzaro, BSN, RN', 'role': 'CONTACT', 'email': 'Araceli.Lazzaro@commonspirit.org', 'phone': '602-406-1156'}, {'name': 'Hursh Naik, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Dignity Health St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Byrne', 'role': 'CONTACT', 'email': 'JESSICA.BYRNE@abrazohealth.com', 'phone': '602-952-0002', 'phoneExt': '7349'}, {'name': 'Timothy Byrne, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Phoenix Cardiovascular Research Group', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalia Elias Calles, MPH', 'role': 'CONTACT', 'email': 'natalia.eliascalles@tmcaz.com', 'phone': '520-324-5512'}, {'name': 'Thomas E. Waggoner, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tucson Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Baptist Health Heart Failure & Transplant Institute', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maylene Alegre', 'role': 'CONTACT', 'email': 'malegre@health.ucsd.edu', 'phone': '858-246-2511'}, {'name': 'Jorge Silva Enciso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92121', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Gil-Flamer', 'role': 'CONTACT', 'email': 'Gil-Flamer.John@scrippshealth.org'}, {'name': 'Matthew Price, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Scripps Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Ramos', 'role': 'CONTACT', 'email': 'Melissa.ramos@med.usc.edu', 'phone': '818-309-5542'}, {'name': 'Ajay Vaidya, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Kaiser Permanente San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacqueline Furrier', 'role': 'CONTACT', 'email': 'Jacqueline.Furrier@ucsf.edu', 'phone': '415-476-4922'}, {'name': 'Liviu Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Roman', 'role': 'CONTACT', 'email': 'William.Roman@hhchealth.org', 'phone': '860-972-1558'}, {'name': 'Bryan Piccirillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hartford Health', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Linda Levesque, RN', 'role': 'CONTACT', 'email': 'Linda.levesque@yale.edu', 'phone': '203-737-6483'}, {'name': 'Lavanya Bellumkonda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Curl', 'role': 'CONTACT', 'email': 'Megan.A.Curl@medstar.net'}, {'name': 'Miguel Pinilla-Vera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medstar Health Research Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'JFK Medical Center', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Holly-Lynn Grospitch', 'role': 'CONTACT', 'email': 'HollyLynn.Grospitch@hcahealthcare.com'}, {'name': 'Saurabh Sanon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HCA Florida Largo Hospital', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Lang', 'role': 'CONTACT', 'email': 'BLang@med.miami.edu', 'phone': '305-298-4471'}, {'name': 'Mrudula Munagala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Corlies', 'role': 'CONTACT'}, {'name': 'Rohit Amin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ascension Sacred Heart', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mia Eifrid', 'role': 'CONTACT', 'email': 'miaeifrid@usf.edu'}, {'name': 'Fadi Matar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristy Pitts', 'role': 'CONTACT', 'email': 'klpitts@emory.edu', 'phone': '404-686-5775'}, {'name': 'Kendra Grubb, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anila Lokhandwala', 'role': 'CONTACT', 'email': 'cardiology.research@northside.com', 'phone': '404-303-3355'}, {'name': 'Mehrdad Toosi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronica Herzog', 'role': 'CONTACT', 'email': 'vherzog@bsd.uchicago.edu'}, {'name': 'Gene Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60515', 'city': 'Downers Grove', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jill Lux', 'role': 'CONTACT', 'email': 'Jillian.Lux@aah.org', 'phone': '630-730-6343'}, {'name': 'Dominick Bufalino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advocate Good Samaritan Hospital', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jillian Bruenn', 'role': 'CONTACT', 'email': 'jfrick2@kumc.edu', 'phone': '913-588-9720'}, {'name': 'Mark Wiley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meredith Thunberg', 'role': 'CONTACT', 'email': 'Meredith.thunberg@cckheart.com'}, {'name': 'Bassem Chehab, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiovascular Research Institute of Kansas', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': 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