Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices
- Conditions
- Heart Failure
- Registration Number
- NCT00811551
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Little Rock Cardiology Clinic
🇺🇸Little Rock, Arkansas, United States
The Emory Clinic - Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Midwest Heart Research Foundation
🇺🇸Lombard, Illinois, United States
Colorado Springs Cardiology
🇺🇸Colorado Springs, Colorado, United States
St. Thomas Hospital Heart
🇺🇸Nashville, Tennessee, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States