Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

NCT01917266 | Completed DMC

• 1 other identifier: SJM-CIP-10084
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 months after implant

Study Arms (2)

Concordant

Discordant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Herzzentrum Leipzig GmbH

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 6, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

DE (1)