N/A
Completed N=65
Optimize RV Follow-up Selective Site Pacing Clinical Trial
Cardiac Pacing · Right Ventricular Pacing · Left Ventricular Ejection Fraction
Source: ClinicalTrials.gov NCT00949715 ↗
Enrolled (actual)
65
Serious AEs
—
Results posted
Oct 2013
Primary outcomePrimary: Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month — 48.3; 51.2 percentage of LVEF — p=0.2352
Summary
The purpose of the Optimize RV Follow-Up study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of selective site pacing is to improve how the heart contracts when paced.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month |
48.3; 51.2 | 0.2352 |
| SECONDARY Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group. |
-13.5; -14.6 | 0.7405 |
| SECONDARY Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group. |
55.0; 43.7 | 0.1051 |
| SECONDARY Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups. |
59.2; 49.3 | 0.9835 |
Eligibility Criteria
Inclusion Criteria
- Subjects enrolled in the Optimize RV study (version 3, dated 6 March 2007)
- Subjects or legal guardians who are willing and able to sign an Informed Consent (and Authorization to use and Disclose Health Information Form, if applicable)
Exclusion Criteria
- Subjects who have a device that was programmed outside the Optimize RV programming requirements
- Subjects implanted with and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
- Subjects who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT00949715). 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.