Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-01-29 @ 6:24 PM
Study NCT ID:
NCT03305393
Status:
TERMINATED
Last Update Posted:
2019-09-19
First Post:
2017-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002037', 'term': 'Bundle-Branch Block'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to terminate the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ejection fraction', 'timeFrame': '12 Months', 'description': 'Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization'}, {'measure': 'NYHA functional class', 'timeFrame': '12 months', 'description': 'Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation burden', 'timeFrame': '12 Months', 'description': 'Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review'}, {'measure': 'Heart failure hospitalizations', 'timeFrame': '12 months', 'description': 'Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects'}, {'measure': 'Left ventricular end systolic volume', 'timeFrame': '12 months', 'description': 'As determined by echocardiographic evidence'}, {'measure': 'Time to first appropriate therapy for VT and/or VF', 'timeFrame': '12 months', 'description': 'Time determined by device interrogation from sensing to response'}, {'measure': 'Percentage of RV synchronized LV pacing', 'timeFrame': '12 months', 'description': 'Percentage determined by device interrogation and compared to clinical outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'CRT', 'Cardiac Recynchronization Therapy', 'left bundle branch block', 'atrio-ventricular conduction'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal AV conduction (SAV\\<220 ms or PAV\\<270 MS)\n* Left Bundle Branch Block (defined as \\> or = to 140 ms (male) or \\> or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)\n* Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.\n* Sinus Rhythm at the time of enrollment\n\nExclusion Criteria:\n\n* Moderate to severe Aortic Stenosis\n* Moderate to severe Mitral Regurgitation\n* Patient age \\<18 years old\n* AF burden \\>15%\n* Severe pulmonary disease requiring supplemental oxygen use\n* ESRD\n* System Modification at RRT Generator Changeout\n* AdaptivCRT prior to enrollment\n* Expected patient longevity \\< 1 year\n* Persistant or chronic atrial fibriliation\n* Women who are pregnant or who plan to become pregnant during the clinical trial'}, 'identificationModule': {'nctId': 'NCT03305393', 'briefTitle': 'Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stern Cardiovascular Foundation, Inc.'}, 'officialTitle': 'Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement', 'orgStudyIdInfo': {'id': 'IMPROVE RESPONSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adaptiv CRT', 'description': 'Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit', 'interventionNames': ['Device: Adaptiv CRT']}], 'interventions': [{'name': 'Adaptiv CRT', 'type': 'DEVICE', 'description': 'Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit', 'armGroupLabels': ['Adaptiv CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Stern Cardiovascular Foundation', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stern Cardiovascular Foundation, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}