Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-01 @ 10:08 AM
Study NCT ID:
NCT04375332
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2020-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beating Heart Mitral Valve Repair With the HARPOON™ System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in NYHA classification from Baseline to 5 years', 'timeFrame': 'Baseline compared to 1 and 5 years', 'description': "The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.\n\nClass II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.\n\nClass III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.\n\nClass IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.\n\nSymptoms of heart failure or the anginal syndrome may be present even at rest."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).', 'detailedDescription': 'RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEach subject is required to meet all of the following inclusion criteria:\n\n1. Patient is \\>/= 21 years old.\n2. Presence of severe degenerative mitral regurgitation with mid-segment posterior leaflet prolapse (without commissural involvement) by echocardiographic study.\n3. Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without undue leaflet tension, based on the judgment of the Echocardiographic Core Lab.\n4. Patient competent to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation.\n\nExclusion Criteria:\n\nPatients will be excluded if ANY of the following criteria apply:\n\n1. Functional mitral regurgitation (FMR).\n2. Evidence of anterior or bileaflet prolapse.\n3. Severe mitral annular calcification (MAC).\n4. Moderate or greater leaflet calcification.\n5. Fragile or thinning apex (e.g. LV aneurysm).\n6. Have undergone cardiac or peripheral vascular procedures within 30 days prior to the trial procedure.\n7. Planned cardiac or peripheral vascular procedures within 30 days after the trial procedure.\n8. Requirement for concomitant cardiac surgery.\n9. Severe pulmonary hypertension (pulmonary artery systolic pressure \\> 60mmHg).\n10. Severe aortic stenosis or insufficiency.\n11. Severe tricuspid regurgitation. (Patients with mild or moderate tricuspid regurgitation are not excluded.)\n12. Left ventricular ejection fraction (LVEF) \\<30%, or severely impaired right ventricular dysfunction as measured by the core lab.\n13. Any history of endocarditis.\n14. Contraindication to cardiac surgery, including hostile chest or history of mediastinal radiation.\n15. Previous structural heart intervention (e.g. any heart valve replacement or repair procedures). Previous percutaneous coronary intervention (PCI) is allowed.\n16. Previous coronary artery bypass grafting (CABG).\n17. Stroke within 30 days prior to index procedure.\n18. ST segment elevation myocardial infarction (STEMI) requiring intervention within 30 days prior to index procedure.\n19. Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, \\[or MELD score of ≥ 13\\]).\n20. Renal insufficiency CKD Stage 3b or worse (GFR \\< 45 ml/min/1.73 m2).\n21. Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g. requiring inotropic support or mechanical support devices).\n22. History of bleeding diathesis or coagulopathy or leukopenia (WBC \\< 3000 mcL) or acute anemia (Hb \\< 9 g/dL) or thrombocytopenia (platelets \\< 50,000 cells mcL).\n23. Active SARS-CoV-2 infection (Coronavirus-19 \\[COVID-19\\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments (as assessed by Case Review Committee).\n24. Refuse blood products.\n25. Planned treatment with any other investigational device or procedure through 1-year follow-up, or who are currently participating in an investigational drug or device trial.\n26. Carotid stenosis ≥ to 80% at time of enrollment.\n27. Rheumatic heart disease including rheumatic mitral stenosis.\n28. Pregnant or lactating at the time of enrollment (women of childbearing age should have negative pregnancy test within 72 hours of surgery) or planning pregnancy within the next 12 months.\n29. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator.\n30. Condition or conditions that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.\n31. Contraindication for transesophageal echocardiography (TEE), including esophageal spasm, esophageal stricture, esophageal laceration, esophageal perforation, esophageal diverticula (e.g. Zenker's diverticulum).\n32. Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or appendage thrombus, myxoma, or vegetation).\n33. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen.\n\n Intra-operative exclusion criteria\n34. No longer meets eligibility criteria based on intra-operative assessment."}, 'identificationModule': {'nctId': 'NCT04375332', 'acronym': 'RESTORE', 'briefTitle': 'Beating Heart Mitral Valve Repair With the HARPOON™ System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)', 'orgStudyIdInfo': {'id': '2019-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HARPOON™ Beating Heart Mitral Valve Repair System', 'description': 'Subjects who were treated with the HARPOON™ Beating Heart Mitral Valve Repair System', 'interventionNames': ['Device: HARPOON™ Beating Heart Mitral Valve Repair System']}], 'interventions': [{'name': 'HARPOON™ Beating Heart Mitral Valve Repair System', 'type': 'DEVICE', 'description': 'Repair of the chordae tendinae in the mitral valve.', 'armGroupLabels': ['HARPOON™ Beating Heart Mitral Valve Repair System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cardiovascular Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Heart Institute', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}], 'overallOfficials': [{'name': 'Vinod H. Thourani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Cardiovascular Surgery, Piedmont Heart Institute'}, {'name': 'Konstantinos Koulogiannis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiovascular Medicine Gagnon Cardiovascular Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}