Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT00148967
Status:
COMPLETED
Last Update Posted:
2006-11-22
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013610', 'term': 'Tachycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017147', 'term': 'Defibrillators, Implantable'}], 'ancestors': [{'id': 'D047548', 'term': 'Defibrillators'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 1535}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2005-10'}, 'lastUpdateSubmitDate': '2006-11-20', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.'}], 'secondaryOutcomes': [{'measure': 'The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI:'}, {'measure': 'The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life'}]}, 'conditionsModule': {'keywords': ['right ventricular pacing', 'implantable cardioverter defibrillator'], 'conditions': ['Tachycardia']}, 'referencesModule': {'references': [{'pmid': '22016074', 'type': 'DERIVED', 'citation': 'Sullivan RM, Russo AM, Berg KC, Stolen KQ, Seth M, Perschbacher D, Day JD, Olshansky B. Arrhythmia rate distribution and tachyarrhythmia therapy in an ICD population: results from the INTRINSIC RV trial. Heart Rhythm. 2012 Mar;9(3):351-8. doi: 10.1016/j.hrthm.2011.10.018. Epub 2011 Oct 19.'}, {'pmid': '19901194', 'type': 'DERIVED', 'citation': 'Ahmadi-Kashani M, Kessler DJ, Day J, Bunch TJ, Stolen KQ, Brown S, Sbaity S, Olshansky B; INTRINSIC RV Study Investigators. Heart rate predicts outcomes in an implantable cardioverter-defibrillator population. Circulation. 2009 Nov 24;120(21):2040-5. doi: 10.1161/CIRCULATIONAHA.108.847608. Epub 2009 Nov 9.'}, {'pmid': '18996055', 'type': 'DERIVED', 'citation': 'Bunch TJ, Day JD, Olshansky B, Stolen KQ, Mullin CM; INTRINSIC RV Study Investigators. Newly detected atrial fibrillation in patients with an implantable cardioverter-defibrillator is a strong risk marker of increased mortality. Heart Rhythm. 2009 Jan;6(1):2-8. doi: 10.1016/j.hrthm.2008.09.025. Epub 2008 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.', 'detailedDescription': 'The purpose of study is to assess whether AVSH will provide benefits of a dual-chamber ICD without the deleterious effects of unnecessary RV pacing. This study will aim to demonstrate that DDDR-AVSH is equal to VVI with respect to mortality and HF hospitalizations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who meet VITALITY™AVT® ICD indications\n* Patients who sign and date a Patient Informed Consent prior to device implant\n* Patients who remain in the clinical care of the enrolling physician\n\nExclusion Criteria:\n\n* Patients with current indication for CRT-D\n* Patients who previously had a pacemaker, ICD or CRT-D\n* Patients with chronic AF\n* Patients whose life expectancy is \\<12 months due to other medical conditions\n* Patients who are expected to receive a heart transplant during the duration of the study\n* Patients with epicardial pacing leads\n* Patients who have CABG, PCI, cardiac or other arrhythmia surgery planned but not yet performed\n* Patients with or who are likely to receive a tricuspid or other valve prosthesis\n* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study\n* Patients who are younger than 18 years of age\n* Patients who are pregnant\n* Patients who are mentally incompetent and cannot give Patient Informed Consent or participate in the study'}, 'identificationModule': {'nctId': 'NCT00148967', 'briefTitle': 'INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs', 'orgStudyIdInfo': {'id': 'CR-CA-051403-T'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implantable Cardioverter Defibrillator', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Brian Olshansky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}, {'name': 'John Day, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utah Heart Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}}}}