Phase 4
N=93
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00187200 ↗Enrolled (actual)
93
Serious AEs
17.5%
Results posted
Sep 2015
Primary outcome: Primary: CRT Responder Rate — 16; 20; 17; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Simultaneous VV Pacing (Device); Sequential VV Pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CRT Responder Rate |
16; 20; 17; 6 | — |
| SECONDARY NYHA Class Progression |
11; 17; 1; 1; 17; 7 | — |
| SECONDARY 6 Minute Hall Walk Distance Test (6-MHWD) |
10; 13; 20; 13 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
30.6; 30.7; 32.6; 32.1 | — |
Summary
The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.
For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
* 1 heart failure (HF) related hospitalization, and
* no class improvement or worsening in NYHA scale.
Eligibility Criteria
Inclusion Criteria
- Patient has a standard indication for a CRT-D.
- Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
- Patients requiring a CRT-D replacement must comply with BOTH of the following:
- > 1 HF related hospitalization
- No class improvement or worsening in NYHA scale
Exclusion Criteria
- Patient's life expectancy is less than 12 months.
- Patient has had cardiac surgery within 6 months of enrollment.
- Patient has an epicardial ventricular lead system.
- Patient is less than 18 years old.
- Patient is pregnant.
Data sourced from ClinicalTrials.gov (NCT00187200). 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.