Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-01 @ 9:39 AM
Study NCT ID:
NCT04573166
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2020-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Atrial Septostomy for Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054144', 'term': 'Heart Failure, Diastolic'}], 'ancestors': [{'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', 'interventionModelDescription': 'After left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the levels of AOP and MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. The patency and size of fenestration will be followed up for 12 months. During the period of follow up, the other evaluations will include the improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-02', 'studyFirstSubmitDate': '2020-09-20', 'studyFirstSubmitQcDate': '2020-09-28', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical change', 'timeFrame': '12 months', 'description': 'Distance in 6 minutes walk test'}, {'measure': 'The size of created-fenestration', 'timeFrame': '12 months', 'description': 'The change of created-fenestration size evaluated with echocardiography'}], 'secondaryOutcomes': [{'measure': 'The percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE)', 'timeFrame': '12 months', 'description': 'Peri-procedural, and 12 months MACCE and systemic embolic events in patients after CURB procedure.'}, {'measure': 'Change of PAWP or MLAP at rest', 'timeFrame': '12 months', 'description': 'Pulmonary capillary wedge pressure (PCWP)/MLAP at rest evaluated with right heart catheterization'}, {'measure': 'Change of cardiac remodeling', 'timeFrame': '12 months', 'description': 'The change in cardiac chamber and function evaluated with MSCT and CMR'}, {'measure': 'Myocardial remodeling', 'timeFrame': '12 months', 'description': 'The myocardial molecular imaging evaluated with PET-CT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure; atrial septostomy'], 'conditions': ['Heart Failure', 'Heart Failure, Diastolic']}, 'referencesModule': {'references': [{'pmid': '40425275', 'type': 'DERIVED', 'citation': 'Yan C, Li H, Wan L, Liu A, Yundan P, Guo T, Hua L, Wang L, Fang W. Left atrial pressure normalisation by graded radiofrequency atrial septostomy in heart failure with preserved ejection fraction: a single-arm pilot study. Heart. 2025 Oct 14;111(21):1020-1027. doi: 10.1136/heartjnl-2025-325929.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the safety and efficacy of personalized atrial septostomy (PAS) with combined use of radiofrequency-ablation and balloon-dilation (CURB) in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).', 'detailedDescription': 'Atrial septostomy is an important palliative therapy in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) . Though the safety of balloon atrial septostomy (BAS) is satisfactory, the incidence of spontaneous closure is higher, which limits the clinical utilization of this procedure. The device-implantation improves the long-term patency. However, the created fenestration is limited with fixed size and it is further complicated with the potential device-related complications.\n\nRadiofrequency catheter ablation (RFA) has the potential to cause irreversible damage around the rim of fenestration created with BAS, which might prevent the re-adhesion of the septal remnants. In addition, RFA on fossae ovalis might reduce the elastic recoil of local tissue and contribute to create larger inter-atrial fenestration with same BAS procedure. Therefore, the combined use of radiofrequency-ablation and balloon-dilation (CURB) might become a novel procedure to create a stable inter-atrial fenestration.\n\nIn this study, the adult patients who have HFrEF and HFpEF refractory to medical therapy may be eligible for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Symptomatic heart failure in NYHA class III or IV ambulatory;\n3. Optimal medical therapy of heart failure according to European Society of Cardiology (ESC) guidelines for last 6 months;\n4. LVEF ≥ 45%;\n5. Elevated left heart filling pressures: left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) ≥ 18 mmHg at rest;\n6. LVEDP or PCWP-Mean right atrial pressure (MRAP) ≥ 5 mmHg;\n7. Systolic blood pressure ≥ 90 mmHg.\n\nExclusion Criteria:\n\n1. Acute infection or sepsis;\n2. Intra-cardiac mass, thrombus or vegetation;\n3. Evidence of right heart failure (TAPSE \\< 14 mm);\n4. Pulmonary hypertension (PASP \\> 60 mmHg);\n5. Associated atrial septal defect or large patent foramen ovale with significant left to right shunt in rest;\n6. TIA or stroke within the last 6 months;\n7. Thromboembolic events within the last 6 months;\n8. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy as cause of heart failure;\n9. Valvular diseases requiring therapy according to current ESC guidelines;\n10. Life expectancy \\< 1 year for non-cardiovascular reasons.'}, 'identificationModule': {'nctId': 'NCT04573166', 'acronym': 'PAS', 'briefTitle': 'Personalized Atrial Septostomy for Heart Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Personalized Atrial Septostomy With Combined Use of Radiofrequency-ablation and Balloon-dilation: First-in-human Study in Heart Failure', 'orgStudyIdInfo': {'id': '2020-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CURB procedure', 'description': 'Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (CURB)', 'interventionNames': ['Procedure: Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation']}], 'interventions': [{'name': 'Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation', 'type': 'PROCEDURE', 'description': 'After left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the level of MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. The patency and size of fenestration will be followed up for 6 months. During the period of follow up, the other evaluations will include the improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on.', 'armGroupLabels': ['CURB procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Yan Chaowu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Chaowu Yan, PhD and MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Cardiovascular Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}