N/A
N=78
Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01278030 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Responder Rate — 67; 60 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3D echo-guided LV lead placement (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate |
67; 60 | — |
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.
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
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.