Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 3:08 PM
Study NCT ID:
NCT04068233
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2019-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Pacing Mode and Diastolic Function on Cardiac Output
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054537', 'term': 'Atrioventricular Block'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'It is decided by coin tossing which pacing mode is programmed first (randomization). Sonographer and patient are both blinded to the pacing mode.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each patient will represent their own control, as both pacing modes (asynchronous and synchronous) are applied in each patient.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of left ventricular diastolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.', 'timeFrame': 'During echo examination.', 'description': 'Echo parameters of diastolic function.'}], 'secondaryOutcomes': [{'measure': 'Effect of left ventricular systolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.', 'timeFrame': 'During echo examination.', 'description': 'Echo parameters of systolic function.'}, {'measure': 'Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.', 'timeFrame': 'During echo examination.', 'description': 'Echo parameters of atrial function.'}, {'measure': 'Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.', 'timeFrame': 'During echo examination.', 'description': 'Demographic variables and co-morbidities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diastolic function', 'Cardiac output', 'Pacemaker stimulation mode', 'Stroke volume'], 'conditions': ['Diastolic Function', 'Cardiac Output', 'Pacemaker Stimulation Mode', 'Stroke Volume', 'AV Block']}, 'referencesModule': {'references': [{'pmid': '37265566', 'type': 'DERIVED', 'citation': 'Blessberger H, Kammler J, Kellermair J, Kiblboeck D, Nahler A, Hrncic D, Saleh K, Schwarz S, Reiter C, Fellner A, Eppacher C, Sheldon TJ, Steinwender C. Impact of pacing mode and different echocardiographic parameters on cardiac output (PADIAC). Front Cardiovasc Med. 2023 May 17;10:1185518. doi: 10.3389/fcvm.2023.1185518. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Background It is known from previous research that in patients with complete AV (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are higher with AV-synchronous than with AV-dyssynchronous pacing. However, the extent to which patients profited from AV-synchronous stimulation varied substantially.\n\nAim of the study Aim of this study is to systematically analyze the impact of diastolic function and other echo parameters on the difference of stroke volumes/cardiac output between AV-synchronous and AV-dyssynchronous pacing modes.\n\nMethods Patients fulfilling the entry criteria will be enrolled (two-chamber pacemaker of any vendor eligible) in this monocentric, prospective, interventional study. Baseline data will be collected with a standardized questionnaire. During an echo examination, parameters of diastolic, systolic and atrial function will be assessed. Then, the stroke volume/cardiac output will be measured twice in each patient, once with AV-synchronous and once with AV-dyssynchronous pacing. Therefore, each patient will represent their own control. It will be randomized (coin tossing) which stimulation mode is first and which is second (sonographer and patient will be blinded). Descriptive statistics will be applied and regression models will be fitted to explore the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is able and willing to give informed consent and is above the age of 18.\n* Patient is implanted with a dual chamber pacemaker system for at least 6 weeks.\n* Patient is in sinus rhythm on the day of recruitment.\n* Patient has a ventricular pacing rate exceeding 90%.\n* Upon initial device interrogation, parameters are within normal ranges.\n* Calculated battery life is more than 1 year.\n\nExclusion Criteria:\n\n* Patient is not in sinus rhythm on the day of echo examination.\n* Intrinsic ventricular activation on the day of echo examination.\n* Relevant shunt on the atrial, ventricular or pulmonary level.\n* Moderate or severe heart valve dysfunction (stenosis or regurgitation).\n* Presence of other medical devices that may interact with the pacemaker system.\n* Women who are pregnant or breast feeding.'}, 'identificationModule': {'nctId': 'NCT04068233', 'acronym': 'PADIAC', 'briefTitle': 'Impact of Pacing Mode and Diastolic Function on Cardiac Output', 'organization': {'class': 'OTHER', 'fullName': 'Kepler University Hospital'}, 'officialTitle': 'Impact of Pacing Mode and Diastolic Function on Cardiac Output', 'orgStudyIdInfo': {'id': '01/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eligible patients - pacing mode sequence 1', 'description': 'Echo assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-synchronous pacing mode first, then AV-dyssynchronous pacing mode.', 'interventionNames': ['Other: Pacemaker stimulation mode']}, {'type': 'EXPERIMENTAL', 'label': 'Eligible patients - pacing mode sequence 2', 'description': 'Echo assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-dyssynchronous pacing mode first, then AV-synchronous pacing mode.', 'interventionNames': ['Other: Pacemaker stimulation mode']}], 'interventions': [{'name': 'Pacemaker stimulation mode', 'type': 'OTHER', 'description': 'Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.', 'armGroupLabels': ['Eligible patients - pacing mode sequence 1', 'Eligible patients - pacing mode sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Kepler University Hospital', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'overallOfficials': [{'name': 'Clemens Steinwender, Assoc. Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kepler University Hospital, Department of Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kepler University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Cardiology', 'investigatorFullName': 'Clemens Steinwender', 'investigatorAffiliation': 'Kepler University Hospital'}}}}