N/A
Completed N=400
QuickOpt Chronic Study
Source: ClinicalTrials.gov NCT01172067 ↗Enrolled (actual)
400
Serious AEs
12.0%
Results posted
Sep 2019
Primary outcomePrimary: Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline — -24.69; -25.13 Percent change in LVESV
Summary
The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the CRTP/D patients with different optimization at 12 months after implantation.The hypothesis is that the Heart Remolding parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after implant is not inferior (10%) to the patients by Echo optimization。
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline |
-24.69; -25.13 | — |
Eligibility Criteria
Inclusion Criteria
- • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system
- Patient is able to provide written informed consent for study participation
Exclusion Criteria
- • Patient has limited intrinsic atrial activity (≤ 40 bpm)
- Patient has persistent or permanent AF
- Patient has a 2o or 3o heart block
- Patient's life expectancy is <12 months
- Patient is <18 years old
- Patient is pregnant
- Patient is on IV inotropic agents
- Patients who are ongoing other devices or agents study
- Patients with heart transplanted or waiting for heart transplant
- Patients with Hypertrophic and obstructive cardiomyopathy
- Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement
Data sourced from ClinicalTrials.gov (NCT01172067). 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.