Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT04736667
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2021-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mitral Valve Screening Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Reason for screen failure', 'timeFrame': 'Baseline'}, {'measure': 'All-cause mortality', 'timeFrame': '30 days, 1 year, and annually up to 5 years'}, {'measure': 'Hospitalizations', 'timeFrame': '30 days, 1 year, and annually up to 5 years'}, {'measure': 'Mitral intervention', 'timeFrame': '30 days, 1 year, and annually up to 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Disease']}, 'referencesModule': {'references': [{'pmid': '36266153', 'type': 'DERIVED', 'citation': 'Medranda GA, Rogers T, Modine T, Latib A, Jorde U, Bapat V, Sorajja P, Rowland M, Sutton JA, Baig S, Asch FM, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R. The Clinical Profile and Natural History of Patients Who Fail Screening for Transcatheter Mitral Valve Replacement: Rationale and Design of the Prospective Multicenter Mitral Valve Screening Survey (MVSS). Cardiovasc Revasc Med. 2023 Feb;47:72-75. doi: 10.1016/j.carrev.2022.09.003. Epub 2022 Sep 11.'}, {'pmid': '34600872', 'type': 'DERIVED', 'citation': 'Waksman R, Medranda GA. Transcatheter Mitral Valve Replacement: Size Matters. JACC Cardiovasc Interv. 2021 Oct 25;14(20):2228-2230. doi: 10.1016/j.jcin.2021.08.040. Epub 2021 Sep 29. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).', 'detailedDescription': 'Numerous transcatheter mitral valve interventions have emerged as a treatment option for patients with mitral valve disease. Development of transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) continues to progress with ongoing rigorous clinical trials of several experimental devices. However, despite being referred for TMVI, most patients do not pass stringent screening criteria for these investigational devices and are not offered TMVI.\n\nIn this prospective multicenter registry, baseline demographics, anatomical/imaging characteristics, and clinical outcomes of patients who fail screening for TMVI will be prospectively collected into a registry database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This multicenter prospective study will enroll consecutive subjects, who after referral for TMVI, are deemed not to be candidates for TMVI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject failed screening for TMVI\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Subject unable or unwilling to give informed consent\n* Subject proceeded with TMVI.'}, 'identificationModule': {'nctId': 'NCT04736667', 'acronym': 'MVSS', 'briefTitle': 'Mitral Valve Screening Survey', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Mitral Valve Screening Survey (MVSS)', 'orgStudyIdInfo': {'id': 'MVSS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects fail screening for TMVI', 'description': 'Subjects with symptomatic mitral valve disease who after referral for TMVI, are deemed not to be candidates for TMVI.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Byrne', 'role': 'CONTACT', 'email': 'JESSICA.BYRNE@abrazohealth.com'}, {'name': 'Timothy Byrne, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Phoenix Cardiovascular Research Group', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melody Nazar', 'role': 'CONTACT', 'email': 'Melody.Nazar@med.usc.edu'}, {'name': 'Jose Escobar', 'role': 'CONTACT', 'email': 'Jose.Escobar@med.usc.edu'}, {'name': 'Vaughn Starnes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keck Hospital of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Collins', 'role': 'CONTACT', 'email': 'Erin.C.Collins@medstar.net'}, {'name': 'Jake Sutton', 'role': 'CONTACT', 'email': 'joseph.a.sutton@medstar.net', 'phone': '202-877-6624'}, {'name': 'Ron Waksman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Menezes', 'role': 'CONTACT', 'email': 'John.Menezes@baycare.org'}, {'name': 'Sue Fisher', 'role': 'CONTACT', 'email': 'Susan.Fisher1@baycare.org'}, {'name': 'Joshua Rovin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Morton Plant Hospital', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Deckard', 'role': 'CONTACT', 'email': 'michelle.deckard@leehealth.org'}, {'name': 'Michael DeFrain, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HealthPark Medical Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Mossell', 'role': 'CONTACT', 'email': 'allison.mossell@nm.org'}, {'name': 'Nicole Kappel', 'role': 'CONTACT', 'email': 'nicole.kappel@nm.org'}, {'name': 'Christopher Malaisrie, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kendra Tuttle', 'role': 'CONTACT', 'email': 'Kendra.Tuttle@mercyoneiowa.org'}, {'name': 'Atul Chawla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MercyOne Iowa Heart Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66103', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kartik Munshi', 'role': 'CONTACT', 'email': 'kmunshi@kumc.edu'}, {'name': 'Tilitha Shawgo', 'role': 'CONTACT', 'email': 'tshawgo@kumc.edu'}, {'name': 'Emmanuel Daon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lina Fu', 'role': 'CONTACT', 'email': 'lfu2@partners.org'}, {'name': 'Ignacio Inglessis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Renee Bess', 'role': 'CONTACT', 'email': 'renee.bess@ascension.org'}, {'name': 'Theodore Schreiber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ascension St. John's Hospital", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alison DePaolis', 'role': 'CONTACT', 'email': 'Alison.DePaolis@nyulangone.org'}, {'name': 'Melissa Batteria', 'role': 'CONTACT', 'email': 'Melissa.Batteria@nyulangone.org'}, {'name': 'Richard Schwartz, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health - Long Island', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annie Kellum', 'role': 'CONTACT', 'email': 'Annie.Kellum@osumc.edu'}, {'name': 'Kalyn Ferguson', 'role': 'CONTACT', 'email': 'Kalyn.Ferguson@osumc.edu'}, {'name': 'Konstantinos Boudoulas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '98239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Garwood', 'role': 'CONTACT', 'email': 'garwood@ohsu.edu'}, {'name': 'Taylor Toro', 'role': 'CONTACT', 'email': 'torot@ohsu.edu'}, {'name': 'Harsh Golwala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dena Burke', 'role': 'CONTACT', 'email': 'Dena.Burke@aah.org'}, {'name': 'Denise Bailey', 'role': 'CONTACT', 'email': 'Denise.Coley@aah.org'}, {'name': 'Tanvir Bajwa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Aurora St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Elizabeth Grieve', 'role': 'CONTACT', 'email': 'egrieve@providencehealth.bc.ca'}, {'name': 'Anna Wilhelm', 'role': 'CONTACT', 'email': 'awilhelm@providencehealth.bc.ca'}, {'name': 'Robert Boone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ivana Kandic', 'role': 'CONTACT', 'email': 'Ivana.Kandic@unityhealth.to'}, {'name': 'Alana Harrington', 'role': 'CONTACT', 'email': 'Alana.Harrington@unityhealth.to'}, {'name': 'Neil Fam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Unity Health Toronto; St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Kassandra Lopez', 'role': 'CONTACT', 'email': 'kassandra.lopez@medstar.net', 'phone': '202-877-2452'}, {'name': 'Jake Sutton', 'role': 'CONTACT', 'email': 'joseph.a.sutton@medstar.net', 'phone': '202-877-6624'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}