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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CRT-D (Intra-thoracic Impedance Monitoring)

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No