Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00811551
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2008-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2008-12-17', 'studyFirstSubmitQcDate': '2008-12-18', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Impedance Monitoring', 'Wedge Pressure'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'zWedge is a clinical feasibility IDE study. The objective is to characterize the relationship between intra-thoracic impedance measurements obtained from a CRT-D device and pulmonary capillary wedge pressure (PCWP) measured via a right heart catheterization (RHC) acutely and over time.', 'detailedDescription': 'Intra-thoracic impedance will be obtained at programmed intervals by using an investigational monitoring feature in the CRT-D device. To obtain impedance values, the device delivers a sub-threshold impulse that measures the resistance between 2 electrodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects previously implanted with a St. Jude Medical PROMOTE device (Model 3207 or other with similar capability) according to ACC/AHA/HRS guidelines.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a SJM PROMOTE CRT-D (Model 3207 or other model with similar functioning) system that was implanted at least 4 months prior to enrollment for an approved indication per ACC/AHA/HRS guidelines.\n* Have the ability to provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation.\n* Have legally marketed bipolar right atrial and true bipolar right ventricular pacing defibrillation leads, and a legally marketed endocardial bipolar LV lead.\n\nExclusion Criteria:\n\n* Be less than 18 years of age.\n* Have any medical condition that would interfere with intra-thoracic measurements such as end-stage pulmonary disease, advanced interstitial pulmonary disease, or frequent episodes of pneumonia.\n* Have a contraindication for right heart catheterization.\n* Have a contraindication for the delivery of IV Nitroglycerin.\n* Be pregnant or planning a pregnancy for the duration of their study participation.\n* Be currently participating in a clinical investigation that includes an active treatment arm.\n* Have a life expectancy of less than 12 months due to any condition.\n* Be unable to perform the Valsalva maneuver with airway pressure \\> 40 mm Hg for ≥10 seconds.\n* Are pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.'}, 'identificationModule': {'nctId': 'NCT00811551', 'acronym': 'zWedge', 'briefTitle': 'Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'zWedge Clinical Feasibility IDE Study', 'orgStudyIdInfo': {'id': 'CRD 440'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CRT-D (Intra-thoracic Impedance Monitoring)', 'type': 'DEVICE', 'description': 'Diagnostic Feature in CRT-D device that emits a sub-threshold pulse to measure resistance between two electrodes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Little Rock Cardiology Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Memorial Hospital', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Cardiology', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic - Crawford Long Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60148', 'city': 'Lombard', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Heart Research Foundation', 'geoPoint': {'lat': 41.88003, 'lon': -88.00784}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Thomas Hospital Heart', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Mark Carlson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Medical Devices'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}