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

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.

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.