Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

Abbott Medical Devices1 site in 1 country40 target enrollmentJuly 2013

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 40
Locations: 1
Primary Endpoint: Percent of patients with the left ventricle (LV) lead implanted at the site of latest mechanical activation
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in subjects with concordant versus discordant left ventricular (LV) lead position as compared to the site of latest mechanical activation.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

July 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be scheduled to undergo implant of a Cardiac Resynchronization Therapy (CRT) system with approved standard indication per accepted guidelines as a new implant or an upgrade from an existing Implantable Cardioverter Defibrillator (ICD) or pacemaker with no prior left ventricular lead placement
•Be in sinus rhythm at the time of enrollment
•Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations

Exclusion Criteria

•Have persistent or permanent atrial fibrillation
•Be in New York Heart Association (NYHA) IV functional class
•Have prior left ventricular (LV) lead implant
•Be pacemaker-dependent
•Have a recent myocardial infarction within 40 days prior to enrollment
•Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
•Have had a recent Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months prior to enrollment
•Have had intravenous inotropic support in the last 30 days
•Exhibit Cheyne-Stokes respiration
•Be less than 18 years of age

Outcomes

Primary Outcomes

Percent of patients with the left ventricle (LV) lead implanted at the site of latest mechanical activation

Time Frame: This outcome measure will be assessed after an off-line analysis immediately after implant

Secondary Outcomes

Response to Cardiac Resynchronization Therapy (CRT) as defined by percent change in end-systolic volume (ESV) at 6-month follow-up relative to baseline.(6 months after implant)