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

NCT00811551 | Completed

• 1 other identifier: CRD 440
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 7

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.

Conditions

Heart Failure

Keywords

Heart Failure; Impedance Monitoring; Wedge Pressure

Interventions

CRT-D (Intra-thoracic Impedance Monitoring) DEVICE

Diagnostic Feature in CRT-D device that emits a sub-threshold pulse to measure resistance between two electrodes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (7)

Little Rock Cardiology Clinic

Little Rock, Arkansas, 72211, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Colorado Springs Cardiology

Colorado Springs, Colorado, 80907, United States

Location

The Emory Clinic - Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Midwest Heart Research Foundation

Lombard, Illinois, 60148, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

St. Thomas Hospital Heart

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mark Carlson, MD

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 19, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (7)