Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-01 @ 3:10 PM
Study NCT ID:
NCT01774357
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2013-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'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'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2054}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2013-01-21', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and types of AF-related complications', 'timeFrame': '24 months'}, {'measure': 'Time to occurrence of first AF-related complication', 'timeFrame': '24 months'}, {'measure': 'Time to AF-related intervention after detection of de novo or worsening AF', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Frequency and type of complications related to implantation', 'timeFrame': '24 months'}, {'measure': 'Frequency and type of lead-related complications', 'timeFrame': '24 months'}, {'measure': 'All-cause mortality', 'timeFrame': '24 months'}, {'measure': 'Cardiovascular hospitalization with days in hospital', 'timeFrame': '24 months'}, {'measure': 'Significance of AF in acute decompensation of heart failure', 'timeFrame': '24 months'}, {'measure': 'Interventions based on Home Monitoring information regarding AF', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Tachycardia', 'ICD Therapy', 'Thromboembolic Events', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months. All analyses on the data will be done post-hoc; the study does not intend to confirm any pre-specified hypotheses.', 'detailedDescription': 'Enrollment (E0)\n\nTiming:\n\n• The enrollment (date of patient written informed consent) starts after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system according to current guidelines (primary or secondary prevention) but should not be later than 90 days after implantation.\n\nProcedures:\n\n* Check inclusion and exclusion criteria\n* Patient information and written informed consent process\n* Assignment of a unique study code\n* ICD interrogation (re-programming if necessary)\n* HMSC registration (recommended)\n* Investigator assessment: appropriate atrial sensing\n\nDocumentation (note: where available the most recent assessment recorded within six months prior to hospital discharge shall be considered):\n\n* Medical History:\n\n * Demographic data\n * General history of cardiovascular disease\n * Etiology of underlying heart disease\n * Cardiac events and symptoms\n * Documented supraventricular arrhythmia prior to implantation\n* Device Interrogation\n\n * Date, home monitoring function, MRI scan\n* AF history:\n\n * type (none, paroxysmal, persistent, permanent)\n * date of first diagnosis (if applicable)\n * EHRA classification (if applicable)\n * AF burden (if available)\n * CHA2DS2-VASc\n * Risk factors and comorbidities:\n * thyroid dysfunction\n * diabetes mellitus\n * COPD\n * sleep apnea\n * chronic renal disease\n * History of thromboembolic events or stroke\n* Physical Examination:\n\n * Vital signs (SBP, DBP, height, body weight, BMI)\n * Current medication (substance class)\n * Heart failure indices\n * NYHA classification\n * BNP and NT-proBNP (only if determined in routine clinical practice)\n * LVEF (optional; echocardiography preferred, other methods accepted if no echo available)\n * ECG parameters (12 lead ECG; optional)\n * RR, PQ, and QT intervals\n * QRS width\n * rhythm disorders\n * clinical findings, morphology\n* Implantation:\n\n * Indication (primary prevention, secondary prevention)\n * Type of procedure (first implantation / replacement)\n * RV lead:\n * Dislodgement / repositioning after implantation?\n * Sufficient amplitudes (Atrial; Ventricular) and thresholds (Ventricular)\n * Other clinical complications during / after implantation?\n * Final lead position at discharge (apical, septal, other)\n * Atrial dipole (with or without atrial wall contact at rest)\n * Ease of implantation as assessed by investigator\n * An extended questionnaire including more detailed information on implantation procedure, technique and initial measurements will be requested as an optional documentation where data are available\n\nFollow-up Y1 and Y2\n\nTiming:\n\n• 12 and 24 months (+/-2 months) after enrollment respectively\n\nProcedures:\n\n* ICD interrogation / function check-up and re-programming if necessary\n* Programmer download of all data not yet submitted to BIOTRONIK according to current working instruction\n* Investigator assessment: appropriate atrial sensing\n\nDocumentation (note: where available the most recent assessment recorded between the current and the preceding visit shall be considered):\n\n* Physical Examination:\n\n * Vital signs (SBP, DBP, height, body weight, BMI)\n * Current medication (substance class)\n * Heart Failure indices:\n * NYHA classification\n * BNP and NT-proBNP (only if determined in routine clinical practice)\n * LVEF (optional; echocardiography preferred, other methods accepted if no echo available)\n * ECG parameters (12 lead ECG; optional):\n * RR, PQ, and QT intervals\n * QRS width\n * rhythm disorders\n * clinical findings, morphology\n* Device Interrogation\n\n * Date, home monitoring function, MRI scan\n\nEvent based documentation\n\n* New-onset or worsening AF\n* AF interventions\n* Worsening heart failure\n* Shock episode\n* Thromboembolic events (CVA, TIA, PAE)\n* Continuous surveillance / reporting of (serious) adverse events / (serious) adverse device effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines and after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines\n* Implanted with a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment\n* Written informed consent, willingness and ability to comply with the protocol\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Any limitation to contractual capability\n* Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study\n* Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment\n* Simultaneous participation in another study\n* Life expectancy \\< 2 years'}, 'identificationModule': {'nctId': 'NCT01774357', 'acronym': 'MATRIX', 'briefTitle': 'Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems', 'orgStudyIdInfo': {'id': 'TA102'}}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Gerhard Hindricks, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzzentrum Leipzig, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}