Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT01519739
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-27
• Primary Completion: 2012-05
• Study Completion: 2012-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The performance of the MediGuide™ system during CRT implant	1 month post CRT implant	Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.