NL-OMON34649
Completed
Phase 2
eft Ventricular Lead Acute Clinical Study - LILAC
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart Failure - Cardiac decompensation
- Sponsor
- Boston Scientific
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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