Status:
COMPLETED
Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 p...
Detailed Description
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 im...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Have legally marketed bipolar right atrial and true bipolar right ventricular pacing defibrillation leads, and a legally marketed endocardial bipolar LV lead.
Exclusion
- Be less than 18 years of age.
- 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.
- Have a contraindication for right heart catheterization.
- Have a contraindication for the delivery of IV Nitroglycerin.
- Be pregnant or planning a pregnancy for the duration of their study participation.
- Be currently participating in a clinical investigation that includes an active treatment arm.
- Have a life expectancy of less than 12 months due to any condition.
- Be unable to perform the Valsalva maneuver with airway pressure \> 40 mm Hg for ≥10 seconds.
- Are pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00811551
Start Date
December 1 2008
End Date
April 1 2011
Last Update
February 4 2019
Active Locations (7)
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1
Little Rock Cardiology Clinic
Little Rock, Arkansas, United States, 72211
2
Huntington Memorial Hospital
Pasadena, California, United States, 91105
3
Colorado Springs Cardiology
Colorado Springs, Colorado, United States, 80907
4
The Emory Clinic - Crawford Long Hospital
Atlanta, Georgia, United States, 30308