Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00811551
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00811551
Study Brief:
Protocol Section:
NCT00811551