Heart Failure - Cardiac decompensation
Conditions
Interventions
None listed
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients who are scheduled to receive (new implant or upgrade) either CRT-P or CRT-D system based on physician discretion • Patients who are scheduled to have an LV lead implantation based on physician discretion • Patients who are expected to tolerate approximately 30 minutes of study testing procedures per physician discretion • Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center • Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
Exclusion criteria: • Patients who are allergic to the contrast media used in the study • Patients who have a history of pocket or device related infection • Patients who have any previous cardiac surgery within the last 3 months • Patients who have concomitant cardiac surgery • Patients who have unstable angina • Patients who have myocardial infarction within the last 3 months • Patients who are dependent on IV inotropes • Patients who are in acute cardiac failure crisis • Women of childbearing potential who are, or might be, pregnant at the time of the study (method of assessment upon physician*s discretion) • Patients whose age is more than 80 years • NYHA class IV patients • Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of this study is to characterize the electrical performance of a dual zone, quadpolar lead design in order to specify the electrode placement location on the spiral fixation of the lead body | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secundary objectives of this study are to: 1. Evaluate the anatomic fit of the short and long straight tip leads 2. Measure the phrenic nerve stimulation threshold if it occurs during the pacing threshold testing and evaluate ability to mitigate PNS by switching pacing zones/locations 3. Evaluate the ability of the leads to be delivered and placed to the selected sites within the coronary branch veins using the standard CRT delivery tools and over-the-wire technique | — |
Countries
Netherlands
Outcome results
None listed