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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811551
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : July 25, 2012
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment
Heart Failure Device: CRT-D (Intra-thoracic Impedance Monitoring)

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.

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: zWedge Clinical Feasibility IDE Study
Study Start Date : December 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Intervention Details:
    Device: CRT-D (Intra-thoracic Impedance Monitoring)
    Diagnostic Feature in CRT-D device that emits a sub-threshold pulse to measure resistance between two electrodes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects previously implanted with a St. Jude Medical PROMOTE device (Model 3207 or other with similar capability) according to ACC/AHA/HRS guidelines.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811551

United States, Arkansas
Little Rock Cardiology Clinic
Little Rock, Arkansas, United States, 72211
United States, California
Huntington Memorial Hospital
Pasadena, California, United States, 91105
United States, Colorado
Colorado Springs Cardiology
Colorado Springs, Colorado, United States, 80907
United States, Georgia
The Emory Clinic - Crawford Long Hospital
Atlanta, Georgia, United States, 30308
United States, Illinois
Midwest Heart Research Foundation
Lombard, Illinois, United States, 60148
United States, Massachusetts
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
United States, Tennessee
St. Thomas Hospital Heart
Nashville, Tennessee, United States, 37205
Sponsors and Collaborators
St. Jude Medical
Study Director: Mark Carlson, MD St. Jude Medical

Responsible Party: St. Jude Medical Identifier: NCT00811551     History of Changes
Other Study ID Numbers: CRD 440
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by St. Jude Medical:
Heart Failure
Impedance Monitoring
Wedge Pressure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases