Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-26 @ 7:04 PM
Study NCT ID:
NCT04914468
Status:
RECRUITING
Last Update Posted:
2021-06-04
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hamburg TranscathEteR Mitral Valve REplacement RegiStry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Standardized methods for sample collection, processing, and storage, as well as appropriate storage facilities, are established and managed in accordance with the highest scientific and ethical standards. To ensure uniformity, quality, and reproducibility for the collection, processing, and storage of biomaterial, standard operating procedures (SOPs) are implemented.\n\nThe following biomaterial will be sampled for additional biobanking within study visits:\n\n* Blood (whole blood, serum, plasma (EDTA, citrated,), DNA, RNA, washed erythrocytes\n* Urine\n* Tissue/ cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '6-60 months', 'description': 'Incidence of death from any cause.'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '6-60 months', 'description': 'Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.'}, {'measure': 'Rehospitalization for congestive heart failure', 'timeFrame': '6-60 months', 'description': 'Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.'}, {'measure': 'Unplanned mitral valve intervention', 'timeFrame': '6-60 months', 'description': 'Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or assist device implantation, e.g. as assessed by patient interviews.'}, {'measure': 'Mitral regurgitation (MR) severity', 'timeFrame': '6-60 months', 'description': 'Mitral regurgitation (MR) severity measured by transthoracic and/or transesophageal echocardiography. Assessment of MR severity according to current recommendations for valvular heart disease.'}], 'secondaryOutcomes': [{'measure': 'Change in 6-minute-walking-test (6MWT) distance', 'timeFrame': '6-60 months', 'description': '6MWT will be performed by all participants at baseline and at follow-up visits.'}, {'measure': 'Change in quality of life', 'timeFrame': '6-60 months', 'description': 'Quality of life will be assessed by a standardized questionnaire \\[Kansas City Cardiomyopathy Questionnaire \\[KCCQ\\]) in all participants at baseline and at follow-up visits (or by phone interviews).\n\nThe score is represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and a score of 100 indicates no symptoms, no limitations, and excellent quality of life.'}, {'measure': 'Change in New York Heart Association (NYHA) functional class', 'timeFrame': '6-60 months', 'description': 'New York Heart Association \\[NYHA\\] functional class (I-IV) will be assessed in all participants at baseline and at follow-up visits (or by phone interviews).\n\nNYHA Class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.\n\nNYHA Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.\n\nNYHA Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.\n\nNYHA Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Disease']}, 'descriptionModule': {'briefSummary': 'The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that undergo transcatheter mitral valve replacement (TMVR) screening. In particular, long-term durability and function of implanted bioprosteses is of utmost interest for both patients and clinicians. Moreover, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR.', 'detailedDescription': 'Mitral valve regurgitation (MR) emerges as the most frequent valvular heart disease in developed coun-tries with prevalence increasing with age. Mitral valve repair is the gold standard therapeutic strategy in primary MR and is recommended in patients with secondary MR who are in need of revascularization. However, in patients with secondary MR mitral valve repair is associated with a higher rate of MR recurrence compared to mitral valve replacement. Nevertheless, elderly patients often are at high or prohibitive surgical risk and up to one half of all patients with severe MR are not referred to surgery. Transcatheter edge-to-edge mitral valve repair (TEER) constitutes a feasible and effective alternative, but eligibility for TEER is limited in some cases due to suboptimal anatomy or risk of mitral stenosis. Moreover, MR reduction is less predictable and, again, MR may reoccur. Transcatheter mitral valve replacement (TMVR) represents a complementary therapeutic approach for patients with severe MR. This novel therapy promises to reduce MR as durable as surgical valve replacement while reducing the procedural risk with an interventional approach.\n\nThe Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with significant mitral valve disease, at high surgical risk with suboptimal anatomy for TEER, who undergo TMVR screening. In particular, long-term durability and function of implanted bioprosteses will be investigated. Additionally, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR (i.e., TMVR, TEER, surgery and medical therapy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with clinically significant mitral valve regurgitation that undergo screening for Transcatheter Mitral Valve Replacement (TMVR) at University Heart and Vascular Center Hamburg shall be included. This includes inpatients and outpatients of the University Heart and Vascular Center Hamburg and may be extended to patients from other national or foreign centers. Inclusion into the study will take place after written informed consent is obtained. Patients included in interventional device studies (e.g., early feasibility TMVR studies, post-market TMVR studies etc.) may also be included in HERMES.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation.\n* Individuals over the age of 18 years.\n* Patients with clinically relevant mitral valve disease, who undergo screening for TMVR.\n\nExclusion Criteria:\n\n* Insufficient knowledge of the German language, to understand study documents and interview without translation\n* Physical or psychological incapability to cooperate in the investigation'}, 'identificationModule': {'nctId': 'NCT04914468', 'acronym': 'HERMES', 'briefTitle': 'Hamburg TranscathEteR Mitral Valve REplacement RegiStry', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Hamburg Transcatheter Mitral Valve Replacement Registry', 'orgStudyIdInfo': {'id': 'HERMES'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TMVR', 'description': 'Patients undergoing Transcatheter Mitral Valce Replacement (TMVR)'}, {'label': 'TEER', 'description': 'Patients undergoing mitral Transcatheter Edge-to-Edge Repair (TEER) after screening for TMVR'}, {'label': 'Surgery', 'description': 'Patients undergoing mitral valve surgery (repair or replacement) after screening for TMVR'}, {'label': 'Medical therapy', 'description': 'Patients undergoing medical therapy after screening for TMVR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Ludwig, MD', 'role': 'CONTACT'}, {'name': 'Daniel Kalbacher, MD', 'role': 'CONTACT'}, {'name': 'Edith Lubos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Heart and Vascular Center Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Sebastian Ludwig, MD', 'role': 'CONTACT', 'email': 'se.ludwig@uke.de', 'phone': '+49-40-7410-0'}], 'overallOfficials': [{'name': 'Sebastian Ludwig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heart and Vascular Center Hamburg'}, {'name': 'Edith Lubos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heart and Vascular Center Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}