Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

Abbott

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT01917266

SJM-CIP-10084

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Be pregnant or planning to become pregnant during the duration of the investigation
• Be currently participating in any other clinical investigation

Trial design

40 participants in 2 patient groups

Concordant

Discordant