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

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: CRT-D (Intra-thoracic Impedance Monitoring)

Study type: Observational

Funder types: Industry

Identifiers

NCT00811551

CRD 440

Details and patient eligibility

About

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.

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.