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

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: MediGuide™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519739

CR-11-043-EU-MG

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

MediGuide Arm

Experimental group

Treatment:

Device: MediGuide™