N/A Completed N=78 Randomized Double-blind Treatment

Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates

Heart Failure

Source: ClinicalTrials.gov NCT01278030 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcomePrimary: Responder Rate — 67; 60 percentage of participants

Summary

The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead placement.

Outcome Measures

Outcome	Result	p-value
PRIMARY Responder Rate	67; 60	—

Eligibility Criteria

Inclusion Criteria

Patients will be implanted with an FDA approved St. Jude Medical CRT-D device (i.e. PROMOTE® or newer devices with similar functionality)
Patients will have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D
Patients will receive a new implant or an upgrade from an existing pacemaker or Implantable Cardiovertor Defibrillator with no prior Left Ventricular lead placement
Patients must be in sinus rhythm at the time of enrollment visit and baseline measurements

Exclusion Criteria

Persistent or permanent atrial fibrillation
Heart transplantation
Recent myocardial infarction (< 90 days)
Contra-indication to contrast agent
Are less than 18 years of age
Are pregnant
Are currently participating in a clinical investigation that includes an active treatment arm
Have a life expectancy of less than 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01278030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.