Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00811551

Run by

Abbott Medical Devices

People needed

22

Starts

2008-12-01

Expected to finish

2011-04-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Little Rock Cardiology Clinic — Little Rock, Arkansas, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• Colorado Springs Cardiology — Colorado Springs, Colorado, United States
• The Emory Clinic - Crawford Long Hospital — Atlanta, Georgia, United States
• Midwest Heart Research Foundation — Lombard, Illinois, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• St. Thomas Hospital Heart — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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