Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 7:59 AM
Study NCT ID:
NCT01287234
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2011-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrio-Ventricular (AV) Delay Optimization Using Echocardiography Versus the SonR Signal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-18', 'studyFirstSubmitDate': '2011-01-28', 'studyFirstSubmitQcDate': '2011-01-29', 'lastUpdatePostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal blood flow method', 'timeFrame': '3 months', 'description': 'To determine the best method of timing the contractions of the top and bottom chambers of the heart by using echocardiography versus using signals of the external SonR sensor.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators will then compare the timing settings suggested by SonR to the settings suggested from the echocardiogram. The objective of this study is to determine if differences exist between these different methods of timing the contractions of the top and bottom chambers of the heart and if the SonR signal is able to produce results similar to those of an echocardiogram.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Implanted with any current Food and Drug Administration (FDA) approved CRT- D device and leads for 30 days or patients indicated for AV optimization\n* ≥18 years of age\n* Ability and willingness to provide written informed consent and HIPAA authorization\n\nExclusion Criteria:\n\n* Chronic Atrial Fibrillation\n* Heart Failure decompensation event within two weeks of enrollment\n* Hypertrophic Obstructive Cardiomyopathy\n* Patient currently enrolled in another ongoing clinical trial\n* Pregnancy\n* Less than 18 years of age\n* Inability or unwillingness to provide written informed consent and HIPAA authorization'}, 'identificationModule': {'nctId': 'NCT01287234', 'acronym': 'SonR Pilot', 'briefTitle': 'Atrio-Ventricular (AV) Delay Optimization Using Echocardiography Versus the SonR Signal', 'organization': {'class': 'OTHER', 'fullName': 'Piedmont Healthcare'}, 'officialTitle': 'Atrio-Ventricular Delay Optimization in Patients Implanted With a Cardiac Resynchronization Device Using Echocardiography Versus the SonR Signal: A Pilot Study', 'orgStudyIdInfo': {'id': 'SonR Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All Patients', 'description': 'All patients will have an echocardiogram and SonR sensor readings completed.', 'interventionNames': ['Other: Echocardiogram/SonR']}], 'interventions': [{'name': 'Echocardiogram/SonR', 'type': 'OTHER', 'description': 'All patients will have an echocardiograph and SonR sensor readings', 'armGroupLabels': ['All Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Dan Dan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Piedmont Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Piedmont Healthcare', 'class': 'OTHER'}, 'collaborators': [{'name': 'LivaNova', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}