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OpenTrials
Completed

NCT Number: NCT01917266

Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

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 latest mechanical activation.

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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

Observational

Primary location

Herzzentrum Leipzig GmbH

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Percent of patients with the left ventricle (LV) lead implanted at the site of latest mechanical activation

    Time frame: This outcome measure will be assessed after an off-line analysis immediately after implant

Secondary outcomes

  1. Response to Cardiac Resynchronization Therapy (CRT) as defined by percent change in end-systolic volume (ESV) at 6-month follow-up relative to baseline.

    Time frame: 6 months after implant

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 6, 2013
Registry last updated
Feb 4, 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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