Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT05555966
Status:
UNKNOWN
Last Update Posted:
2022-09-27
First Post:
2022-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CardioInsight 1 RBBB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-22', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricle (LV) end systolic volume reduction', 'timeFrame': '6 months', 'description': 'The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram'}], 'secondaryOutcomes': [{'measure': 'Electrical dyssynchrony index', 'timeFrame': 'During procedure', 'description': 'The acute electrical dyssynchrony indices (the standard deviation of activation times throughout the epicardium) of different methods of CRT delivery. Lower indicate larger improvement.'}, {'measure': 'Hemodynamic response monitoring', 'timeFrame': 'During procedure', 'description': 'monitor the difference in hemodynamic responses of different methods of CRT delivery method. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.'}, {'measure': 'Procedure outcome with optimal CRT delivery', 'timeFrame': 'During procedure', 'description': 'Procedure outcome measured by procedure duration and implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.'}, {'measure': 'Cine images and chest X ray', 'timeFrame': '6 months', 'description': 'Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) of patients will be obtained for evaluation of changes in disease'}, {'measure': 'Echocardiogram parameter: left ventricular systolic and diastolic volume', 'timeFrame': '6 months', 'description': 'left ventricular systolic and diastolic volume at baseline, 3 months and 6 months : , left ventricular ejection fraction, degree of mitral regurgitation, strain imaging will be aggregated to arrive at an overall change in echocardiogram parameters as together they represent integrated heart function collectively, as reflected by the listed echocardiogram parameters.'}, {'measure': 'Multi-dimensional Quality of life changes', 'timeFrame': '6 months', 'description': "change in New York Heart Association (NYHA) class, 6 minute hall walk test, HF Patient Global Assessment Questionnaire and quality of life using Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months."}, {'measure': 'Device set-up parameter :defibrillation threshold', 'timeFrame': '6 months', 'description': 'Device parameters including defibrillation threshold at implant and 6 months follow-up.'}, {'measure': 'Post-operation Complication rate', 'timeFrame': '6 months', 'description': 'Peri-operative and 6 months follow-up complications rate:\n\n1. Thromboembolic event\n2. Dislodgement and migration of pacing leads\n3. Phrenic nerve stimulation\n4. Others'}, {'measure': 'Device set-up parameter :defibrillation sensitivity', 'timeFrame': '6 months', 'description': 'Device set-up parameter :defibrillation sensitivity at implant and 6 months follow-up'}, {'measure': 'Device set-up parameter: lead impedance of pacing leads', 'timeFrame': '6 months', 'description': 'Device set-up parameter: lead impedance of pacing leads at implant and 6 months follow-up'}, {'measure': 'Change in 6 minute hall walk test', 'timeFrame': '6 months', 'description': 'Change in 6 minute hall walk test result, at baseline, 3 months and 6 months.'}, {'measure': 'Change in HF Patient Global Assessment Questionnaire', 'timeFrame': '6 months', 'description': 'HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.'}, {'measure': 'Change in quality of life', 'timeFrame': '6 months', 'description': "Change in quality of life assessed by Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months."}, {'measure': 'Implantation success rate with optimal CRT delivery', 'timeFrame': 'During procedure', 'description': 'Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.'}, {'measure': 'Echocardiogram parameter: left ventricular ejection fraction', 'timeFrame': '6 months', 'description': 'Echocardiogram parameter: left ventricular ejection fraction at baseline, 3 months and 6 months'}, {'measure': 'Echocardiogram parameter: degree of mitral regurgitation', 'timeFrame': '6 months', 'description': 'Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months'}, {'measure': 'Echocardiogram parameter: strain imaging', 'timeFrame': '6 months', 'description': 'Echocardiogram parameter: strain imaging at baseline, 3 months and 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Cardiac resynchronization therapy (CRT) is an established therapy for symptomatic heart failure patients. However, there are still 30 to 40% of studied patients being nonresponder to CRT. The plausible reasons of lack of effect of CRT in these patients include relative less baseline electrical dyssynchrony. The aim of our study is to investigate whether there is an optimal configuration of CRT delivery that varies between patients with different pattern of activation delay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (aged 18 or above) of both sexes\n* Ischemic or non-ischemic cause of heart failure\n* QRS duration \\> 120 ms, non-left bundle branch block (LBBB) type of conduction disturbance\n* NYHA class III or above\n* Informed consent by the patient\n* Already received stable dose of guideline directed medical therapy for at least 3 months\n\nExclusion Criteria:\n\n* LBBB patients\n* Pregnant women\n* Participation in another study\n* Patient with contraindication to left ventricle catheterization by a retrograde aortic approach'}, 'identificationModule': {'nctId': 'NCT05555966', 'acronym': 'CardioInsight1', 'briefTitle': 'CardioInsight 1 RBBB', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy', 'orgStudyIdInfo': {'id': '2017.316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailor-made CRT delivery', 'description': 'Device placement based on Electrical Activation Mapping result', 'interventionNames': ['Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy']}], 'interventions': [{'name': 'Electrical Activation Mapping Guided Cardiac resynchronization therapy', 'type': 'DEVICE', 'description': 'To study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation', 'armGroupLabels': ['Tailor-made CRT delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '999077', 'city': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Daniel Xu', 'role': 'CONTACT', 'email': 'danielxu@cuhk.edu.hk', 'phone': '35051518', 'phoneExt': '1518'}], 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Daniel Xu', 'role': 'CONTACT', 'email': 'danielxu@cuhk.edu.hk', 'phone': '35051518'}], 'overallOfficials': [{'name': 'Bryan Yan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Bryan Ping Yen YAN', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}