Clinical trial NCT00811551: Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices
Official title: zWedge Clinical Feasibility IDE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Impedance Monitoring
Wedge Pressure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Cardiology Clinic
state: Arkansas
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Cardiology
state: Colorado
city: Atlanta
country: United States
facility: The Emory Clinic - Crawford Long Hospital
state: Georgia
city: Lombard
country: United States
facility: Midwest Heart Research Foundation
state: Illinois
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Nashville
country: United States
facility: St. Thomas Hospital Heart
state: Tennessee
Study officials:
affiliation: Abbott Medical Devices
name: Mark Carlson, MD
role: STUDY_DIRECTOR
References: