Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

January 31, 2019 updated by: Abbott Medical Devices
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • Herzzentrum Leipzig GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients indicated for a Cardiac Resynchronization Therapy (CRT) device

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Concordant
Discordant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
This outcome measure will be assessed after an off-line analysis immediately after implant

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months after implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJM-CIP-10084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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