Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-01 @ 1:47 AM
Study NCT ID:
NCT03706833
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2018-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1247}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2018-10-12', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).', 'timeFrame': '30 days.'}, {'measure': 'PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.', 'timeFrame': '6 months'}, {'measure': 'PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.', 'timeFrame': 'From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up'}], 'secondaryOutcomes': [{'measure': 'Rates of various adverse events', 'timeFrame': '6 months; 12 months', 'description': 'Rates of various adverse events at 6 and 12 months'}, {'measure': 'Functional Improvement (increase in 6 minute walk test in meters)', 'timeFrame': '30 days , 6 months, 1 year', 'description': 'Increase in 6 minute walk test in meters'}, {'measure': 'Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years', 'timeFrame': '30 days , 6 months, 1 year, 2 year', 'description': 'Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life'}, {'measure': 'Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years', 'timeFrame': '30 days, 6 months, 1 year, 2 year', 'description': 'Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life'}, {'measure': 'Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through', 'timeFrame': '30 days, 6 months, 1 year, 2 year', 'description': 'Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degenerative Mitral Valve Disease', 'Mitral Regurgitation', 'Mitral Insufficiency', 'Functional Mitral Regurgitation']}, 'referencesModule': {'references': [{'pmid': '38099912', 'type': 'DERIVED', 'citation': 'Marcoff L, Koulogiannis K, Aldaia L, Mediratta A, Chadderdon SM, Makar MM, Ruf TF, Gossler T, Zaroff JG, Leung GK, Ku IA, Nabauer M, Grayburn PA, Wang Z, Hawthorne KM, Fowler DE, Dal-Bianco JP, Vannan MA, Bevilacqua C, Meineri M, Ender J, Forner AF, Puthumana JJ, Mansoor AH, Lloyd DJ, Voskanian SJ, Ghobrial A, Hahn RT, Mahmood F, Haeffele C, Ong G, Schneider LM, Wang DD, Sekaran NK, Koss E, Mehla P, Harb S, Miyasaka R, Ivannikova M, Stewart-Dehner T, Mitchel L, Raissi SR, Kalbacher D, Biswas S, Ho EC, Goldberg Y, Smith RL, Hausleiter J, Lim DS, Gillam LD; CLASP IID Pivotal Trial Investigators. Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Imaging. 2024 May;17(5):471-485. doi: 10.1016/j.jcmg.2023.09.015. Epub 2023 Dec 13.'}, {'pmid': '36725171', 'type': 'DERIVED', 'citation': "Hausleiter J, Lim DS, Gillam LD, Zahr F, Chadderdon S, Rassi AN, Makkar R, Goldman S, Rudolph V, Hermiller J, Kipperman RM, Dhoble A, Smalling R, Latib A, Kodali SK, Lazkani M, Choo J, Lurz P, O'Neill WW, Laham R, Rodes-Cabau J, Kar S, Schofer N, Whisenant B, Inglessis-Azuaje I, Baldus S, Kapadia S, Koulogiannis K, Marcoff L, Smith RL; PASCAL IID Registry Investigators. Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation. J Am Coll Cardiol. 2023 Feb 7;81(5):431-442. doi: 10.1016/j.jacc.2022.11.034."}, {'pmid': '36121247', 'type': 'DERIVED', 'citation': "Lim DS, Smith RL, Gillam LD, Zahr F, Chadderdon S, Makkar R, von Bardeleben RS, Kipperman RM, Rassi AN, Szerlip M, Goldman S, Inglessis-Azuaje I, Yadav P, Lurz P, Davidson CJ, Mumtaz M, Gada H, Kar S, Kodali SK, Laham R, Hiesinger W, Fam NP, Kessler M, O'Neill WW, Whisenant B, Kliger C, Kapadia S, Rudolph V, Choo J, Hermiller J, Morse MA, Schofer N, Gafoor S, Latib A, Koulogiannis K, Marcoff L, Hausleiter J; CLASP IID Pivotal Trial Investigators. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2523-2536. doi: 10.1016/j.jcin.2022.09.005. Epub 2022 Sep 17."}]}, 'descriptionModule': {'briefSummary': 'To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)', 'detailedDescription': 'A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)\n\nPatients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eighteen (18) years of age or older\n* Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.\n* Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).\n* Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)\n* Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip\n* Mitral regurgitation (3+ to 4+) by echo\n* Suitable valve and regurgitant jet morphology\n* Elevated corrected BNP \\> 400 pg/ml or corrected NT-pro BNP of \\> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)\n* LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)\n\nExclusion Criteria:\n\n* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful\n* Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation\n* Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)\n* Clinically significant, untreated coronary artery disease\n* Recent stroke\n* Other severe valve disorders requiring intervention\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months\n* Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)\n* Severe tricuspid regurgitation or tricuspid valve disease requiring surgery\n* Active rheumatic heart disease or rheumatic etiology for MR\n* Severe aortic stenosis or regurgitation\n* Known history of untreated, severe carotid stenosis\n* Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)\n* Severe COPD\n* Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception\n* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator\n* Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment\n* Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship'}, 'identificationModule': {'nctId': 'NCT03706833', 'acronym': 'CLASP IID/IIF', 'briefTitle': 'Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation', 'orgStudyIdInfo': {'id': '2018-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Edwards PASCAL System - CLASP IID', 'description': 'Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation', 'interventionNames': ['Device: Edwards PASCAL System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abbott Mitraclip System - CLASP IID', 'description': 'Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation', 'interventionNames': ['Device: Abbott Mitraclip System']}, {'type': 'EXPERIMENTAL', 'label': 'Edwards PASCAL System - CLASP IIF', 'description': 'Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation', 'interventionNames': ['Device: Edwards PASCAL System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abbott Mitraclip System - CLASP IIF', 'description': 'Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation', 'interventionNames': ['Device: Abbott Mitraclip System']}, {'type': 'EXPERIMENTAL', 'label': 'Edwards PASCAL System - Single-Arm Registry', 'description': 'Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.', 'interventionNames': ['Device: Edwards PASCAL System']}], 'interventions': [{'name': 'Edwards PASCAL System', 'type': 'DEVICE', 'otherNames': ['Transcatheter Mitral Valve repair (TMVr)'], 'description': 'Transcatheter mitral valve repair with the Edwards PASCAL System', 'armGroupLabels': ['Edwards PASCAL System - CLASP IID', 'Edwards PASCAL System - CLASP IIF', 'Edwards PASCAL System - Single-Arm Registry']}, {'name': 'Abbott Mitraclip System', 'type': 'DEVICE', 'otherNames': ['Transcatheter Mitral Valve repair (TMVr)'], 'description': 'Transcatheter mitral valve repair with the Abbott Mitraclip System', 'armGroupLabels': ['Abbott Mitraclip System - CLASP IID', 'Abbott Mitraclip System - CLASP IIF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Theresa Jorgensen', 'role': 'CONTACT', 'email': 'Theresa.Jorgensen@bannerhealth.com', 'phone': '602-839-5716'}, {'name': 'Marvin Eng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Banner University 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, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abrazo Arizona Heart Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Arizona Cardiovascular Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Marsh', 'role': 'CONTACT', 'email': 'Mary.Marsh@TMCAZ.com', 'phone': '520-324-4143'}, {'name': 'Thomas Waggoner, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Neil Gheewala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'TMC Healthcare', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92071', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christina Nava', 'role': 'CONTACT', 'email': 'nava.christina@scrippshealth.org', 'phone': '858-824-5244'}, {'name': 'Elideth Silva (Amador)', 'role': 'CONTACT', 'email': 'Amador.Elideth@scrippshealth.org', 'phone': '858 824-5244'}, {'name': 'Matthew Price, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Scripps Memorial Hospital La Jolla', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'PIH Health Good Samaritan Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitch Gheorghiu', 'role': 'CONTACT', 'email': 'Mitch.Gheorghiu@cshs.org', 'phone': '310-423-6152'}, {'name': 'Raj Makkar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ethan Lai', 'role': 'CONTACT', 'email': 'laiew@hs.uci.edu', 'phone': '714-509-2778'}, {'name': 'Julissa Ramirez', 'role': 'CONTACT', 'email': 'julisr5@hs.uci.edu', 'phone': '714-509-2778'}, {'name': 'Antonio Frangieh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95618', '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': 'Kimberly Marinovich', 'role': 'CONTACT', 'email': 'Kimberly.Marinovich@sutterhealth.org', 'phone': '916-887-4737'}, {'name': 'Pei-Hsiu Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sutter Medical Center-Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sutter Bay Area', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Hirota', 'role': 'CONTACT', 'email': 'jessica.g.hirota@kp.org', 'phone': '415-833-7325'}, {'name': 'Quyen Chau', 'role': 'CONTACT', 'email': 'quyen.x.chau@kp.org', 'phone': '415-833-3468'}, {'name': 'Andrew Rassi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], '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': 'Justin Cortez', 'role': 'CONTACT', 'email': 'Justin.cortez@ucsf.edu', 'phone': '415-514-0527'}, {'name': 'Sammy Elmariah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tiffany Flores', 'role': 'CONTACT', 'email': 'Tflores2@stanford.edu', 'phone': '650-206-3345'}, {'name': 'Tiffany Koyano', 'role': 'CONTACT', 'email': 'Tkoyano3@standford.edu', 'phone': '650-206-0141'}, {'name': 'William Hiesinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mane Arabyan', 'role': 'CONTACT', 'email': 'Mane.Arabyan@Hcahealthcare.com', 'phone': '805-796-3746'}, {'name': 'Saibal Kar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Los Robles Hospital and Medical Center', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dori Burnette', 'role': 'CONTACT', 'email': 'Dori.burnette@uchealth.org', 'phone': '970-624-5296'}, {'name': 'Dulce Hayes', 'role': 'CONTACT', 'email': 'Dulce.hayes@uchealth.org', 'phone': '970-624-16883'}, {'name': 'Justin Strote, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Center of the Rockies', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Collins, MPH', 'role': 'CONTACT', 'email': 'Erin.c.collins@medstar.net', 'phone': '202-877-6622'}, {'name': 'Lowell Satler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medstar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Murrhee', 'role': 'CONTACT', 'email': 'Demurrhee@tcavi.com', 'phone': '352-244-0208', 'phoneExt': 'opt # 6'}, {'name': 'Brandy Baudoin', 'role': 'CONTACT', 'email': 'BBaudoin@tcavi.com', 'phone': '325-244-0208', 'phoneExt': 'Opt # 4'}, {'name': 'Charles Klodell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Cardiac and Vascular Institute Research Foundation', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Giselle Cortez-Vargas', 'role': 'CONTACT', 'email': 'Giselle.CortezVargas@msmc.com', 'phone': '305-674-2121', 'phoneExt': '56022'}, {'name': 'Beatriz Acevedo', 'role': 'CONTACT', 'email': 'Beatriz.Acevedo@msmc.com', 'phone': '305-674-2121', 'phoneExt': '56022'}, {'name': 'Nirat Beohar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Steve Xydas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathy Byrd, RN', 'role': 'CONTACT', 'email': 'Kathy.Byrd@nchmd.org', 'phone': '239-624-8113'}, {'name': 'Anessa Diers', 'role': 'CONTACT', 'email': 'Anessa.Diers@nchmd.org', 'phone': '239-624-8115'}, {'name': 'Robert Cubeddu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NCH Healthcare System Naples', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Pelley', 'role': 'CONTACT', 'email': 'jennifer.pelley@adventhealth.com', 'phone': '407-303-8059'}, {'name': 'Chantie Garvey', 'role': 'CONTACT', 'email': 'Chantie.garvey@adventhealth.com', 'phone': '407-303-8059'}, {'name': 'Kevin Accola, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patrice Harris', 'role': 'CONTACT', 'email': 'Patrice.Harris@piedmont.org', 'phone': '470-371-3240'}, {'name': 'Claire Tucker', 'role': 'CONTACT', 'email': 'Claire.Tucker@piedmont.org', 'phone': '404-605-5151'}, {'name': 'Pradeep Yadavs, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Piedmont Healthcare', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United 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