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

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT00811551
Collaborator
(none)
22
Enrollment
7
Locations
28
Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
22 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
zWedge Clinical Feasibility IDE Study
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Little Rock Cardiology Clinic Little Rock Arkansas United States 72211
    2 Huntington Memorial Hospital Pasadena California United States 91105
    3 Colorado Springs Cardiology Colorado Springs Colorado United States 80907
    4 The Emory Clinic - Crawford Long Hospital Atlanta Georgia United States 30308
    5 Midwest Heart Research Foundation Lombard Illinois United States 60148
    6 Lahey Clinic Medical Center Burlington Massachusetts United States 01805
    7 St. Thomas Hospital Heart Nashville Tennessee United States 37205

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT00811551
    Other Study ID Numbers:
    • CRD 440
    First Posted:
    Dec 19, 2008
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Abbott Medical Devices
    Heart Failure
    Impedance Monitoring
    Wedge Pressure
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Feb 4, 2019