Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01917266

Enrollment

Registered

2013-08-06

Start date

2013-07-31

Completion date

2017-07-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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.	6 months after implant

Countries

Germany

Outcome results