eft Ventricular Lead Acute Clinical Study

Phase 2

Completed

Conditions: Heart Failure - Cardiac decompensation
10019280

Registration Number: NL-OMON34649

Lead Sponsor: Boston Scientific

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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
• NYHA class IV patients
• Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objectives of this study is to characterize the electrical<br /><br>performance of a dual zone, quadpolar lead design in order to specify the<br /><br>electrode placement location on the spiral fixation of the lead body</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Secundary objectives of this study are to:<br /><br><br /><br>1. Evaluate the anatomic fit of the short and long straight tip leads<br /><br>2. Measure the phrenic nerve stimulation threshold if it occurs during the<br /><br>pacing threshold testing and evaluate ability to mitigate PNS by switching<br /><br>pacing zones/locations<br /><br>3. Evaluate the ability of the leads to be delivered and placed to the selected<br /><br>sites within the coronary branch veins using the standard CRT delivery tools<br /><br>and over-the-wire technique</p><br>