Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-30 @ 5:51 PM
Study NCT ID:
NCT03311295
Status:
TERMINATED
Last Update Posted:
2021-04-28
First Post:
2017-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Lagging enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Major Adverse Event Rate to 30 Days post-procedure', 'timeFrame': '30 days post procedure', 'description': 'Major Adverse Events (MAEs) will be categorized and defined in accordance with the relation to the procedure and device.'}, {'measure': 'Efficacy: Mitral regurgitation grade by ASE criteria and change from baseline to 1 year', 'timeFrame': 'Baseline to 1 year', 'description': 'Mitral regurgitation grade by ASE criteria and change from baseline to 1 year evaluated by 2-D transthoracic echocardiogram'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Mitral Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nCandidates must meet ALL of the following criteria to be enrolled in the study.\n\n* Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent\n* Age 21-85, inclusive\n* Trans-septal catheterization is determined to be feasible by the treating physician\n* NYHA class II-IV heart failure of any etiology\n* Symptomatic with MR grade ≥ 2+\n* LVEF \\< 40%\n* LVEDD \\> 50 mm and ≤ 75 mm\n* No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.\n* In the opinion of the investigator and heart surgery team, the patient is not an appropriate candidate for surgery, and the use of the ARTO System is technically feasible\n\nExclusion Criteria:\n\nCandidates will be excluded from enrollment in the study if ANY of the following conditions apply.\n\n* In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present\n* Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)\n* Significant mitral annular calcification\n* Hemodynamic instability (systolic pressure \\< 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)\n* Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD\n* History of, or active, rheumatic heart disease\n* History of Atrial Septal Defects (ASD), whether repaired or not\n* History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure\n* In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing\n* Serum creatinine \\> 2.5 mg/dL or dialysis dependent\n* No access to coronary sinus and/or great cardiac vein\n* Platelet count \\< 100 x 103 cells/mm3\n* Evidence of active infection (fever with temperature \\> 38°C and/or WBC \\> 15,000) or endocarditis\n* Echocardiographic evidence of mass intracardiac thrombus\n* Patients on prescribed dual antiplatelet therapy (asprin + any P2Y12 inhibitor) that cannot be discontinued.\n* Percutaneous coronary intervention or surgery anticipated within the 6 month follow up period following the investigational procedure\n* Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure\n* Evidence of an acute myocardial infarction within 12 weeks of the planned investigational procedure\n* Stroke or TIA within 6 months of the planned investigational procedure\n* GI bleeding within 6 months of the planned investigational procedure\n* Intravenous drug abuse or suspected inability to adhere to follow-up\n* Patients in whom TTE, TEE or ICE is contraindicated\n* Contraindication to CT scan\n* A known hypersensitivity or contraindication to study or procedure medications (specifically aspirin, clopidogrel and heparin) that cannot be adequately managed medically\n* A known allergy or hypersensitivity to nickel\n* A known need for any other cardiac surgery including surgery for coronary artery disease, atrial fibrillation, pulmonic, aortic or tricuspid valve disease\n* In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads\n* Irreversible bleeding disorder, history of bleeding diathesis or coagulopathy or refuses blood transfusion\n* Evidence of disease or condition expected to compromise survival (\\< 1 year) or ability to complete follow-up assessments\n* Pregnant or breastfeeding women\n* Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. \\[Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials\\]\n* Patient not a candidate for emergent surgical bailout in case of need"}, 'identificationModule': {'nctId': 'NCT03311295', 'acronym': 'MAVERIC US', 'briefTitle': 'MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mvrx, Inc.'}, 'officialTitle': 'MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States', 'orgStudyIdInfo': {'id': 'US042616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARTO System', 'interventionNames': ['Device: ARTO System']}], 'interventions': [{'name': 'ARTO System', 'type': 'DEVICE', 'description': 'The ARTO System directly reshapes the mitral annulus promoting leaflet coaptation and amelioration of regurgitation.', 'armGroupLabels': ['ARTO System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Reginald Low, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University California Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mvrx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}