Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-05 @ 6:37 PM
Study NCT ID:
NCT06526195
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 850}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Finkelstein-Schoenfeld Win Ratio', 'timeFrame': '5 years', 'description': 'The Finkelstein-Schoenfeld Win Ratio will be explored at 5 years as an additional analysis with the following hierarchy:\n\n1. Survival\n2. Days alive outside of the hospital\n3. Quality of Life assessed with the KCCQ (considered a tie if within 10 points)\n4. Functional Capacity (Six-minute walk distance)\n\nThe Finkelstein-Schoenfeld Win Ratio will be analyzed between the HM3 Group and the Control Group within the Randomized population. Additionally, the Finkelstein-Schoenfeld Win Ratio will be descriptively analyzed between the Single Arm and both the HM3 Group and Control Group of the Randomized Arm separately.'}, {'measure': 'Survival free of urgent LVAD or transplant', 'timeFrame': '5 years', 'description': 'This additional descriptive analysis at 5-years will be performed to evaluate the proportion of patients who are alive and free of device replacement or transplant in the HM3 Group compared to the Single Arm Registry (de novo implant or transplant)'}], 'primaryOutcomes': [{'measure': 'Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes', 'timeFrame': '2 years', 'description': 'The powered primary endpoint will be analyzed at 2 years following the Com-Nougue method and will be compared between the HM3 Group (HM3 LVAD) and the Control Group (GDMT) within the Randomized population.\n\nPrimary Endpoint definitions:\n\n* Disabling stroke: Modified Rankin Score ≥ 2 at 60 days post-stroke with an increase of at least 1 point compared to the pre-stroke baseline.\n* Urgent heart transplantation: United Network for Organ Sharing (UNOS) listing status 1-3 or equivalent\n* Enrollment into hospice: admission requiring palliative care for cardiovascular reasons.\n* Temporary mechanical circulatory support: short-term univentricular or biventricular support, extracorporeal membrane oxygenation (ECMO), intra-aortic balloon pump (IABP), Impella, Percutaneous VAD, etc.\n* Dependence on intravenous inotropes: patients are considered inotrope-dependent when attempts to wean result in deteriorating hemodynamics, exacerbation of HF symptoms, or progressive organ dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Freedom from major adverse events (MAE) in the HM3 group', 'timeFrame': '1 year', 'description': 'The powered secondary endpoint of freedom from MAE at 1-year will be evaluated in the As-Treated HM3 group against a pre-specified performance goal.\n\nComponents of MAE consist of the following:\n\n* Disabling stroke (Modified Rankin Score ≥ 2 at 60 days post-stroke with an increase of at least 1 point compared to the pre-stroke baseline)\n* Non-surgical bleeding (\\>14 days post implant) requiring hospitalization\n* Driveline infection requiring hospitalization'}, {'measure': 'Survival at 2 years', 'timeFrame': '2 years', 'description': 'The powered secondary endpoint of survival at 2-years will be compared between the HM3 Group and the Control Group within the Randomized population.'}, {'measure': 'Quality of life score assessed with the Kansas City Cardiomyopathy Questionnaire', 'timeFrame': '2 years', 'description': 'The secondary endpoint of Quality of life score at 2-years will be compared between the HM3 Group and the Control Group within the Randomized population. Additionally, the secondary endpoint of Quality of life at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.\n\nThe KCCQ scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. Improvement of KCCQ by at least 10 points is considered clinically significant.'}, {'measure': 'Six-minute walk distance', 'timeFrame': '2 years', 'description': 'The secondary endpoint of six-minute walk distance at 2-years will be compared between the HM3 Group and the Control Group within the Randomized population. Additionally, the secondary endpoint of six-minute walk distance at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.'}, {'measure': 'Hospitalizations for HF and/or Urgent HF Visit', 'timeFrame': '2 years', 'description': 'The secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be compared between the HM3 Group and the Control Group within the Randomized population. Additionally, the secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.'}, {'measure': 'Days alive and outside of the hospital', 'timeFrame': '2 years', 'description': 'The secondary endpoint of days alive and outside of the hospital at 2-years will be compared between the HM3 Group and the Control Group within the Randomized population. Additionally, the secondary endpoint of days alive and outside of the hospital at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.'}, {'measure': 'All-cause hospitalizations', 'timeFrame': '2 years', 'description': 'The secondary endpoint of all-cause hospitalizations at 2-years will be compared between the HM3 Group and the Control Group within the Randomized population. Additionally, the secondary endpoint of all-cause hospitalizations at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Left Ventricular Assist Device (LVAD)', 'Guideline Directed Medical Therapy (GDMT)', 'Non-inotrope Dependent', 'Pulmonary Artery Pressure', 'Hemodynamic Monitoring', 'Medical Management', 'CardioMEMS', 'HeartMate 3 (HM3)', 'Ambulatory Advanced Heart Failure'], 'conditions': ['Heart Failure', 'Heart Diseases', 'Cardiovascular Diseases', 'Pulmonary Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cardiovascular.abbott/us/en/campaigns/team-hf.html', 'label': 'TEAM-HF Clinical Trial Patient Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.', 'detailedDescription': 'Patients with heart failure (HF) suffer from a high degree of morbidity and mortality. Left ventricular assist device (LVAD) therapy has become the standard of care for the treatment of advanced HF patients who are deemed to be dependent on continuous intravenous inotropes, extending life expectancy, enhancing overall quality of life, and improving functional capacity. However, use of LVADs in ambulatory, non-inotrope dependent advanced HF population is limited. Elevated mean pulmonary artery pressure (PAP) secondary to left ventricular failure has emerged as a potential predictor of increased mortality risk for patients refractory to maximally tolerated guideline directed medical therapy (GDMT). In these patients, left ventricular failure with elevated mean PAP may represent objective criteria to identify advanced HF patients requiring heart replacement therapies such as LVAD.\n\nThe TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association (NYHA) Class IIIB/IV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure. Elevated mean PAP will be identified using an implanted PAP monitoring sensor, the CardioMEMS PA Sensor. All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or, if not, will be implanted with the CardioMEMS PA Sensor after enrollment. The overall objectives of TEAM-HF trial are two-fold: 1) To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2) To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT.\n\nThe trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry.\n\nThe TEAM-HF Randomized Arm is a prospective, randomized, open-label study of the HeartMate 3 (HM3) left ventricular assist system (LVAS) versus continued GDMT in non-inotrope dependent HF patients. The objectives of the Randomized Arm are 1) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients with elevated mean PAP are treated with the HM3 compared to being managed on medical therapy alone; and 2) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS.\n\nThe TEAM-HF Single Arm Registry is a prospective, single-arm, open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization. The objective of the Single Arm Registry is to follow patients with lower mean PAP to evaluate how their HF progresses and if a delayed HM3 implantation would be beneficial for these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure.\n2. LVEF ≤30% and Cardiac Index \\< 2.2 L/min/m².\n3. Limited functional status as demonstrated by 6MWT \\< 300 m due to HF related reasons.\n4. NYHA Class IIIB or NYHA Class IV\n5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months.\n6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant.\n7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group\n\nRandomization Criteria:\n\n1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.\n2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.\n3. mean PAP ≥ 30 mmHg.\n4. The patient will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.\n\nSingle Arm Registry Criteria:\n\n1\\. mean PAP \\<30 mmHg\n\nExclusion Criteria:\n\n1. Subject is \\< 18 years of age at the time of informed consent.\n2. Any use of inotrope therapy in the last 30 days.\n3. Contra-indications to HM3 LVAS or CardioMEMS HF system.\n4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, severe valvular heart disease, or restrictive cardiomyopathy.\n5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.\n6. Existence of ongoing MCS.\n7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.\n8. History of any solid organ transplant.\n9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.\n10. Presence of an active, uncontrolled infection.\n11. Complex congenital heart disease.\n12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.\n13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\\>1 episode) pulmonary embolism and/or deep vein thrombosis.\n14. Planned VAD or Bi-VAD support prior to enrollment.\n15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:\n\n 1. An INR ≥ 2.0 not due to anticoagulation therapy\n 2. An eGFR \\< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.\n 3. Biopsy proven liver cirrhosis.\n 4. Need for chronic renal replacement therapy.\n 5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \\< 30% predicted.\n 6. History of cerebrovascular disease with significant (\\> 80%) uncorrected internal carotid stenosis.\n 7. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.\n16. Any condition other than HF that could limit survival to less than 24 months.\n17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.'}, 'identificationModule': {'nctId': 'NCT06526195', 'acronym': 'TEAM-HF', 'briefTitle': 'Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure', 'orgStudyIdInfo': {'id': 'ABT- CIP-10521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized Arm - HM3 Group', 'description': 'Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the HM3 group will receive the device within 14 days of randomization.', 'interventionNames': ['Device: CardioMEMS HF System', 'Device: HeartMate 3 Left Ventricular Assist System', 'Other: Guideline Medical Directed Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Arm - Control Group', 'description': 'Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the control group will continue their medical therapy per established heart failure guidelines.', 'interventionNames': ['Device: CardioMEMS HF System', 'Other: Guideline Medical Directed Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Single Arm Registry', 'description': 'Patients who do not meet the mean PAP threshold (mean PAP \\<30 mmHg) and are enrolled in the single arm will continue their medical therapy per established heart failure guidelines.', 'interventionNames': ['Device: CardioMEMS HF System', 'Other: Guideline Medical Directed Therapy']}], 'interventions': [{'name': 'CardioMEMS HF System', 'type': 'DEVICE', 'otherNames': ['CardioMEMS', 'CardioMEMS PA Sensor'], 'description': 'The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.', 'armGroupLabels': ['Randomized Arm - Control Group', 'Randomized Arm - HM3 Group', 'Single Arm Registry']}, {'name': 'HeartMate 3 Left Ventricular Assist System', 'type': 'DEVICE', 'otherNames': ['HM3'], 'description': 'The HeartMate 3 LVAS is a mechanical circulatory support pump with Full MagLev Technology that assumes some or all of the workload of the left ventricle. The HeartMate 3 LVAS is used in advanced heart failure patients needing short or long-term mechanical circulatory support.', 'armGroupLabels': ['Randomized Arm - HM3 Group']}, {'name': 'Guideline Medical Directed Therapy', 'type': 'OTHER', 'otherNames': ['GDMT'], 'description': 'Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.', 'armGroupLabels': ['Randomized Arm - Control Group', 'Randomized Arm - HM3 Group', 'Single Arm Registry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abisola Akinbobola', 'role': 'CONTACT', 'email': 'Abisola.Akinbobola@bannerhealth.com', 'phone': '602-857-2052'}, {'name': 'Radha Gopalan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Banner-University Medical Center Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Marren', 'role': 'CONTACT', 'email': 'victoria.marren@baptist-health.org', 'phone': '678-654-0327'}, {'name': 'Patrick Campbell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Health Medical Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Mccall', 'role': 'CONTACT', 'email': 'jessica.mccall@sutterhealth.org', 'phone': '916-887-4654'}, {'name': 'Michael Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sutter Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tyre Richardson', 'role': 'CONTACT', 'email': 'tyre.richardson@ucsf.edu', 'phone': '(209) 650-5302'}, {'name': 'Shweta Motiwala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hellina Birru', 'role': 'CONTACT', 'email': 'hellina.t.birru@medstar.net', 'phone': '202-877-6334'}, {'name': 'Sheikh Farooq, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erikson Walter', 'role': 'CONTACT', 'email': 'erikson.walter@ufl.edu', 'phone': '269-331-9581'}, {'name': 'Mustafa Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shands at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Mejia-Gomez', 'role': 'CONTACT', 'email': 'mejiagm@ccf.org', 'phone': '954-659-5888'}, {'name': 'Mauricio Velez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Bailey', 'role': 'CONTACT', 'email': 'Andrew.Bailey1@piedmont.org', 'phone': '404-605-4098'}, {'name': 'Catherine Marti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Hansen', 'role': 'CONTACT', 'email': 'jennifer.hansen@piedmont.org', 'phone': '706-724-2463'}, {'name': 'Darshak Karia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Piedmont Augusta Hospital', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amuthanayaki Kanagaraj', 'role': 'CONTACT', 'email': 'amuthanayaki.kanagaraj2@wellstar.org', 'phone': '470-793-7554'}, {'name': 'Abdul Bikak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'WellStar Kennestone Hospital', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60181', 'city': 'Oakbrook Terrace', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mairead Delaney', 'role': 'CONTACT', 'email': 'mairead.delaney@aah.org', 'phone': '708-684-4209'}, {'name': 'Vinh Chau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advocate Health & Hospitals Corporation', 'geoPoint': {'lat': 41.85003, 'lon': -87.96451}}, {'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Regina Margiotti', 'role': 'CONTACT', 'email': 'Regina.Margiotti@ascension.org', 'phone': '317-338-6151'}, {'name': 'Ashwin Ravichandran, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Terry Christenson', 'role': 'CONTACT', 'email': 'tchristenson3@kumc.edu', 'phone': '515-210-2626'}, {'name': 'Zubair Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brianna Grimm', 'role': 'CONTACT', 'email': 'briigrimm@uky.edu', 'phone': '859-323-5366'}, {'name': 'Emma Birks, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bronwen Rees-Weidemann', 'role': 'CONTACT', 'email': 'brees-wiedemann@mgh.harvard.edu', 'phone': '617-726-5508'}, {'name': 'Erin Coglianese, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zack Malouf', 'role': 'CONTACT', 'email': 'zmalouf1@hfhs.org', 'phone': '313-585-7068'}, {'name': 'Lindsey Aurora, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Hanson', 'role': 'CONTACT', 'email': 'stephanie.hanson@corewellhealth.org', 'phone': '616-391-0284'}, {'name': 'Matthew Gonzalez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spectrum Health Butterworth Hospital', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kate Jappe', 'role': 'CONTACT', 'email': 'Kate.Jappe@allina.com', 'phone': '612-863-7347'}, {'name': 'Mosi Bennett, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minneapolis Heart Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colleen Irlbeck', 'role': 'CONTACT', 'email': 'Irlbeck.Colleen@mayo.edu', 'phone': '507-266-6879'}, {'name': 'Andrew Rosenbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Huffman', 'role': 'CONTACT', 'email': 'ahuffman@saint-lukes.org', 'phone': '816-932-0391'}, {'name': 'Timothy Fendler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ryan Ruskamp', 'role': 'CONTACT', 'email': 'ryan.ruskamp@unmc.edu', 'phone': '402-836-9779'}, {'name': 'Adam Burdorf, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 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