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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00811551
First received: December 17, 2008
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention
Heart Failure
Device: CRT-D (Intra-thoracic Impedance Monitoring)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: zWedge Clinical Feasibility IDE Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Enrollment: 22
Study Start Date: December 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811551

Locations
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
Investigators
Study Director: Mark Carlson, MD St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00811551     History of Changes
Other Study ID Numbers: CRD 440
Study First Received: December 17, 2008
Last Updated: July 23, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014