Heart Failure Clinical Trial
Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices
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 pressure (PCWP) measured via a right heart catheterization (RHC) acutely and over time.
Full 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 impulse that measures the resistance between 2 electrodes.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There are 7 Locations for this study
Little Rock Arkansas, 72211, United States
Pasadena California, 91105, United States
Colorado Springs Colorado, 80907, United States
Atlanta Georgia, 30308, United States
Lombard Illinois, 60148, United States
Burlington Massachusetts, 01805, United States
Nashville Tennessee, 37205, United States
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