Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

NCT ID: NCT01917266

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Concordant

No interventions assigned to this group

Discordant

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Herzzentrum Leipzig GmbH

Leipzig, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SJM-CIP-10084

Identifier Type: -

Identifier Source: org_study_id

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