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

February 1, 2019 updated by: Abbott Medical Devices

zWedge Clinical Feasibility IDE Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Mark Carlson, MD, Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD 440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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