Heart Failure Clinical Trial

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

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.

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Full 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.

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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.

Study is for people with:

Heart Failure

Estimated Enrollment:

22

Study ID:

NCT00811551

Recruitment Status:

Completed

Sponsor:

Abbott Medical Devices

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There are 7 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

22

Study ID:

NCT00811551

Recruitment Status:

Completed

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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