Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-27 @ 1:08 AM
Study NCT ID:
NCT01930695
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2013-08-21', 'studyFirstSubmitQcDate': '2013-08-26', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of IEGM recording', 'timeFrame': '3 months', 'description': 'to assess if the IEGM Online recordings of the Lumax 640/740 HF-T with DX functionality provide adequate quality to classify the atrial rhythm'}, {'measure': 'Safety of the Lumax 640/740 HF-T with DX functionality based on the Serious Adverse Device Effects related to the DX functionality', 'timeFrame': '3 months', 'description': 'to assess the safety of the Lumax 640/740 HF-T by the analysis of Serious Adverse Device Effects which are related to the DX functionality'}, {'measure': 'Safety of the Lumax 640/740 HF-T with DX functionality based on all, serious and non-serious, Adverse Device Effects related to DX functionality', 'timeFrame': '3 months', 'description': 'to assess the safety of the Lumax 640/740 HF-T with DX functionality by the analysis of all (serious and non-serious) Adverse Device Effects which are related to the DX functionality'}, {'measure': 'Number of patients with maintenance of diagnosis of permanent AF', 'timeFrame': '3 months', 'description': 'to investigate whether the diagnosis of permanent AF at enrollment is maintained after device implantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DX functionality', 'Atrial fibrillation', 'CRT-D indication'], 'conditions': ['Atrial Fibrillation', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '29596906', 'type': 'RESULT', 'citation': 'Sticherling C, Muller D, Schaer BA, Kruger S, Kolb C; Pre-CRAFT investigators. Atrial electrogram quality in single-pass defibrillator leads with floating atrial bipole in patients with permanent atrial fibrillation and cardiac resynchronization therapy. Indian Pacing Electrophysiol J. 2018 Jul-Aug;18(4):140-145. doi: 10.1016/j.ipej.2018.03.005. Epub 2018 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to collect data of the performance and confirm the safety of the DX (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number of implanted leads without sacrificing atrial information. Atrial pacing can not be provided but is not needed in patients with permanent atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart Failure patients with CRT-D indication according to current ESC guidelines and permanent atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* CRT-D indication according to current ESC guidelines (NYHA III/IV; QRS≥120ms; LVEF≤35%; Expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of AV nodal ablation or ventricular rate ≤60bpm at rest and ≤90bpm on exercise)\n* Permanent atrial fibrillation\n* Patients planned to be implanted with BIOTRONIK Lumax 640/740 HF-T\n* Patients planned to be implanted with BIOTRONIK LinoxSmart S DX right ventricular lead (or successors)\n* Patient eligible for programming of DX functionality according to the physicians' decision\n* Patient is willing and able to comply with the CIP and provided written informed consent\n* Patient accepts Home Monitoring® concept and has sufficient GSM/GPRS coverage\n\nExclusion Criteria:\n\n* Patients with any contraindication to CRT-D therapy\n* Patients listed for heart transplantation\n* Life expectancy less than 12 months\n* Pregnant or breast-feeding women\n* Patients under the age of 18\n* Patients with limited contractual capability\n* Participation in any other clinical study"}, 'identificationModule': {'nctId': 'NCT01930695', 'acronym': 'Pre-CRAFT', 'briefTitle': 'Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T', 'orgStudyIdInfo': {'id': 'CR013'}}, 'contactsLocationsModule': {'locations': [{'zip': '29549', 'city': 'Bad Bevensen', 'country': 'Germany', 'facility': 'Herz- und Gefäßzentrum Bad Bevensen', 'geoPoint': {'lat': 53.07923, 'lon': 10.58129}}, {'zip': '44534', 'city': 'Lünen', 'country': 'Germany', 'facility': 'St. Marien-Hospital Lünen', 'geoPoint': {'lat': 51.61634, 'lon': 7.52872}}, {'zip': '80636', 'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '23909', 'city': 'Ratzeburg', 'country': 'Germany', 'facility': 'DRK Mölln-Ratzeburg', 'geoPoint': {'lat': 53.69965, 'lon': 10.77256}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christian Sticherling, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clinical Trial Unit, University Hospital Basel, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}