Status:
COMPLETED
Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.
Eligibility Criteria
Inclusion
- Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
- Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
- Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion
- Currently participating in any other clinical study
- Have prosthetic valves
- Are pregnant or planning pregnancy in the next 1 month
- Are less than 18 years of age
- Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01519739
Start Date
January 1 2012
End Date
November 1 2012
Last Update
October 30 2019
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