Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 4:20 AM
Study NCT ID:
NCT00157794
Status:
TERMINATED
Last Update Posted:
2025-07-03
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EnTRINSIC - EnPulse Trial on Search AV+ Influence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D012804', 'term': 'Sick Sinus Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'whyStopped': 'Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-10', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of right ventricular pacing', 'timeFrame': 'Baseline to 36 months post-implant'}], 'secondaryOutcomes': [{'measure': 'Change in intrinsic AV delay', 'timeFrame': 'Baseline to 36 months post-implant'}, {'measure': 'Hospitalizations because of symptomatic heart failure', 'timeFrame': 'Baseline to 36 months post-implant'}, {'measure': 'Hospitalizations because of symptomatic atrial fibrillation', 'timeFrame': 'Baseline to 36 months post-implant'}, {'measure': 'Medication', 'timeFrame': 'Baseline to 36 months post-implant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sinus Node Disease', 'Pacemaker', 'Dual Chamber Pacemaker'], 'conditions': ['Arrhythmia, Sinus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.kk-sulzbach.de', 'label': 'Knappschaftskrankenhaus Sulzbach'}, {'url': 'http://hch.klinikum.uni-muenchen.de', 'label': 'Klinikum der Universität München -Großhadern'}]}, 'descriptionModule': {'briefSummary': 'Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms\n* Patients treated with a Medtronic pacemaker with Search AV+ algorithm\n\nExclusion Criteria:\n\n* Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction\n* New York Heart Association (NYHA) III/IV\n* Instable angina pectoris\n* Heart valve vitium\n* Persistent AV-block II and III\n* Early diastolic mitral regurgitation\n* Implantable cardioverter defibrillator\n* Participation in other clinical studies\n* Pregnancy or unreliable birth control\n* AV-block under strain'}, 'identificationModule': {'nctId': 'NCT00157794', 'briefTitle': 'EnTRINSIC - EnPulse Trial on Search AV+ Influence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'EnPulse Trial on Search AV+ Influence', 'orgStudyIdInfo': {'id': 'CEN_G_CA_2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Search AV+ algorithm', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Großhadern Herzchirurgische Klinik und Poliklinik', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '13187', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Internistische Praxis Dr. Med. Schade', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'St. Josefs Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '76571', 'city': 'Gaggenau', 'country': 'Germany', 'facility': 'Praxis Dr. Med. Markert', 'geoPoint': {'lat': 48.8, 'lon': 8.33333}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Krankenhaus Martha Maria Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '76135', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'St. Vincentius Kliniken', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '76829', 'city': 'Landau', 'country': 'Germany', 'facility': 'Vinzentius Krankenhaus', 'geoPoint': {'lat': 49.19844, 'lon': 8.11692}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Klinikum der Johannes-Gutenberg-Universität', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '66538', 'city': 'Neunkirchen', 'country': 'Germany', 'facility': 'Städtisches Klinikum Neunkirchen', 'geoPoint': {'lat': 49.34449, 'lon': 7.18045}}, {'zip': '66564', 'city': 'Ottweiler', 'country': 'Germany', 'facility': 'Kreiskrankenhaus Ottweiler', 'geoPoint': {'lat': 49.40133, 'lon': 7.16424}}, {'zip': '66280', 'city': 'Sulzbach', 'country': 'Germany', 'facility': 'Knappschaftskrankenhaus Sulzbach, Medizinische Klinik', 'geoPoint': {'lat': 49.29882, 'lon': 7.05696}}, {'zip': '48231', 'city': 'Warendorf', 'country': 'Germany', 'facility': 'Josephs-Hospital', 'geoPoint': {'lat': 51.95109, 'lon': 7.98756}}, {'city': 'Wittenberg', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dr. Tamm/Dr. Hon', 'geoPoint': {'lat': 51.8661, 'lon': 12.64973}}], 'overallOfficials': [{'name': 'Michael Jakob, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Knappschaftskrankenhaus Sulzbach'}, {'name': 'Peter Lamm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum der Universität München Großhadern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}