Heart Failure
Conditions
Keywords
Heart Failure, Impedance Monitoring, Wedge Pressure
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 pressure (PCWP) measured via a right heart catheterization (RHC) acutely and over time.
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 impulse that measures the resistance between 2 electrodes.
Interventions
DEVICECRT-D (Intra-thoracic Impedance Monitoring)
Diagnostic Feature in CRT-D device that emits a sub-threshold pulse to measure resistance between two electrodes.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed