Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
Study NCT ID:
NCT00399594
Status:
COMPLETED
Last Update Posted:
2015-11-24
First Post:
2006-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-20', 'studyFirstSubmitDate': '2006-11-13', 'studyFirstSubmitQcDate': '2006-11-13', 'lastUpdatePostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in end systolic volume plus reduction in symptoms', 'timeFrame': 'over 12 months'}], 'secondaryOutcomes': [{'measure': 'Minnesota Living with Heart Failure score.', 'timeFrame': 'Change over 12 months'}, {'measure': 'Short form thirty six score.', 'timeFrame': 'Change over 12 months'}, {'measure': 'Specific Activity Scale score.', 'timeFrame': 'Change over 12 months'}, {'measure': 'New York Heart Association class.', 'timeFrame': 'Change over 12 months'}, {'measure': 'Six minute walk distance.', 'timeFrame': 'Change over 12 months'}, {'measure': 'LV volumes.', 'timeFrame': 'Change over 12 months'}, {'measure': 'N-terminal pro-B-type natriuretic peptide.', 'timeFrame': 'Change over 12 months'}, {'measure': 'Mortality', 'timeFrame': 'Study duration'}, {'measure': 'Hospitalization', 'timeFrame': 'Study duration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mechanical dyssynchrony', 'Biventricular pacing', 'Cardiac resynchronization therapy'], 'conditions': ['Heart Failure, Congestive', 'Cardiac Pacing, Artificial', 'Defibrillators']}, 'descriptionModule': {'briefSummary': 'Identifying \\& optimizing strategies to reduce the burden of heart failure is vital. Despite advances in pharmacotherapy, patients with heart failure are at high risk for death \\& hospitalization. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output \\& reduces HF symptoms. However, \\~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response.\n\nThis study will assess whether targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement.', 'detailedDescription': 'Background. Identifying \\& optimizing strategies to reduce the burden of heart failure (HF) is vital. Despite advances in pharmacotherapy, patients with HF are at high risk for death \\& hospitalization. Over 25% of patients with systolic HF have dyssynchronous ventricular contraction that results in paradoxical septal motion, further impairing left ventricular (LV) function \\& HF progression. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output \\& reduces HF symptoms. However, \\~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response.\n\nScreening. Mechanical synchrony is vitally important in optimizing CRT response. Patients will be pre-screened with echocardiograms (echo) \\& CRT provided to only those with dyssynchrony. The predicted rate of CRT response in patients pre-screened for dyssynchrony is estimated at 65%.\n\nCRT response. The combined use of a valid \\& simple measure of functional capacity with a reproducible measure of LV volume is optimal in identifying CRT responders. These outcomes will be assessed using the Specific Activity Scale \\& radionuclide angiography (RNA), respectively.\n\nPrimary hypothesis. Targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement. CRT response will be defined as ≥ 10% relative reduction in LV end systolic volume \\& ≥ 1 Specific Activity Scale class improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LV EF ≤ 0.40 measured within 3 months of enrollment,\n* SAS class 3 or 4 symptoms indicative of moderate to severe functional capacity limitation due to heart failure within 1 month of enrollment.\n* Confirmed dyssynchrony on screening echo (1.1.9), \\&\n* On stable doses of ACE inhibitor or angiotensin II blocker \\& a beta-blocker for ≥ 2 months unless medically contra-indicated.\n* Controlled heart rate if in permanent AF (resting \\<70 \\& maximal \\<120).\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent,\n* Medical condition other than heart failure likely to cause death \\< 1 year,\n* Cardiac transplant planned within 6 months,\n* Known contra-indication to transvenous CRT device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of leads transvenously),\n* Clinically significant myocardial infarction within last 2 months, or\n* Coronary bypass graft surgery ≤ 2 months or coronary angioplasty ≤ 1 month'}, 'identificationModule': {'nctId': 'NCT00399594', 'acronym': 'INCREMENTAL', 'briefTitle': 'Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Investigating Non-response to Cardiac Resynchronization: Evaluation of Methods to Eliminate Non-response & Target Appropriate Lead Location (INCREMENTAL).', 'orgStudyIdInfo': {'id': 'CAH 70-3402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Targeted LV lead placement', 'interventionNames': ['Procedure: A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Usual LV lead placement', 'interventionNames': ['Procedure: B']}], 'interventions': [{'name': 'A', 'type': 'PROCEDURE', 'description': 'LV lead placement in region of latest mechanical velocity (tissue doppler)', 'armGroupLabels': ['A']}, {'name': 'B', 'type': 'PROCEDURE', 'description': 'LV lead placement in standard (lateral / posterolateral) position.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'G1V4G5', 'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Quebec Heart Institute'}], 'overallOfficials': [{'name': 'Derek V Exner, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, {'name': 'Cambridge Heart Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Canada Research Chair in Cardiovascular Clinical Trials', 'investigatorFullName': 'Dr. Derek Exner', 'investigatorAffiliation': 'University of Calgary'}}}}