Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-13 @ 9:53 PM
Study NCT ID:
NCT03825406
Status:
WITHDRAWN
Last Update Posted:
2019-03-22
First Post:
2019-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Wildtype Amyloid After TAVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000686', 'term': 'Amyloidosis'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Dr. Bavry is recruiting the same patients for a NIH trial.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who die or have poor quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': '1 to 2 years post TAVR', 'description': 'Measurement tool is the Kansas City Cardiomyopathy Questionnaire (KCCQ)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyloidosis']}, 'referencesModule': {'availIpds': [{'url': 'http://va.gov', 'type': 'Study Protocol', 'comment': 'Type Study Protocol To request an electronic copy send email to Anthony.bavry@va.gov or debra.robertson1@va.gov'}, {'url': 'http://va.gov', 'type': 'Individual Participant Data Set', 'comment': 'De-identified data set for primary and secondary outcomes measures To request an electronic copy send email to Anthony.bavry@va.gov or Debra.robertson1@va.gov'}]}, 'descriptionModule': {'briefSummary': 'Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary amyloidosis is a different type of disease which requires different treatment.', 'detailedDescription': 'This research is interested in determining how common wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but it is a condition that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This research is interested in determining how prevalent wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR) patients with impaired hemodynamics. Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but this condition is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients that underwent a TAVR procedure at the Malcolm Randall VA Medical Center.\n* Implant of current generation TAVR (i.e. Sapien S3, Evolut R, or Evolut Pro).\n* Willingness to obtain bone scintigraphy if evidence of impaired hemodynamics after valve deployment.\n* Willingness to have blood drawn\n* Willingness to complete SF12 quality of life KCCQ\n\nExclusion Criteria:\n\n--Patient that do not qualify for a TAVR procedure as normal clinical care'}, 'identificationModule': {'nctId': 'NCT03825406', 'briefTitle': 'Prevalence of Wildtype Amyloid After TAVR', 'organization': {'class': 'OTHER', 'fullName': 'North Florida Foundation for Research and Education'}, 'officialTitle': 'Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics', 'orgStudyIdInfo': {'id': '#: 201802928'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anthony Bavry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ACC AHA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Florida Foundation for Research and Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}