Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-16 @ 10:53 AM
Study NCT ID:
NCT05555992
Status:
UNKNOWN
Last Update Posted:
2022-09-27
First Post:
2022-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CardioInsight 2 - Non-responder
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': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12-31', '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': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricle 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 desynchrony index', 'timeFrame': 'During procedure', 'description': 'The acute electrical desynchrony 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. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.'}, {'measure': 'Procedure duration of different methods of CRT delivery', 'timeFrame': 'During procedure', 'description': 'Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.'}, {'measure': 'Implantation success rate of different methods of CRT delivery', 'timeFrame': 'During procedure', 'description': 'Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony 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 parameters: left ventricular systolic and diastolic volume', 'timeFrame': '6 months', 'description': 'Echocardiogram parameters: left ventricular systolic and diastolic volume at baseline, 3 months and 6 months.'}, {'measure': 'Echocardiogram parameters: left ventricular ejection fraction', 'timeFrame': '6 months', 'description': 'Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months'}, {'measure': 'Echocardiogram parameters: degree of mitral regurgitation', 'timeFrame': '6 months', 'description': 'Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months.'}, {'measure': 'Echocardiogram parameters: strain imaging', 'timeFrame': '6 months', 'description': 'Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months'}, {'measure': 'Change in New York Heart Association (NYHA) class', 'timeFrame': '6 months', 'description': 'Overall changes in QoL measured by change in NYHA class 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': 'Change in 6 minute hall walk test', 'timeFrame': '6 months', 'description': 'Compare result of 6 minute hall walk test at baseline, 3 months and 6 months.'}, {'measure': 'Change in HF Patient Global Assessment Questionnaire', 'timeFrame': '6 months', 'description': 'Compare result of 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': 'Device set-up parameter: defibrillation sensitivity', 'timeFrame': '6 months', 'description': 'Device parameters including defibrillation sensitivity at implant and 6 months follow-up.'}, {'measure': 'Device set-up parameter: lead impedance', 'timeFrame': '6 months', 'description': 'Device parameters including lead impedance of pacing leads at implant and 6 months follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation. The purpose of the Electrical Activation Guided CRT for Nonresponders Study is to study the effectiveness of an addition of Hisbundle pacing approach to CRT nonresponder by direct His-bundle pacing to improve the responder rate of nonresponder of conventional CRT and a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual addition of new lead procedure.\n\nConduct of the Investigation This study will include 18 patients already implanted with device delivering conventional CRT that known to have no response to the conventional CRT after 6 months of the CRT therapy from Prince of Wales Hospital, Hong Kong. You will be followed in the device clinic as per usual care after your participation in the study is completed.'}, '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 -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': 'NCT05555992', 'acronym': 'CardioInsight2', 'briefTitle': 'CardioInsight 2 - Non-responder', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy for Non-responder', 'orgStudyIdInfo': {'id': '2018.215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', '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': ['Treatment']}]}, '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', 'phoneExt': '1518'}], 'overallOfficials': [{'name': 'Byran 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'}}}}