Status:
COMPLETED
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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 la...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01917266
Start Date
July 1 2013
End Date
July 1 2017
Last Update
February 4 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04103