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OpenTrials
Completed

NCT Number: NCT01519739

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MediGuide™

Device

MediGuide™ system will be used to guide CRT implants

Primary outcomes

  1. The performance of the MediGuide™ system during CRT implant

    Time frame: 1 month post CRT implant

    Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Clinical Evaluation of Mediguide System in CRT Implants

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2012
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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