Heart Failure
Conditions
Keywords
CRT, heart failure, optimization, Timing cycle optimization methods
Brief 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。
Detailed description
Clinical studies have demonstrated that the AVTI from QuickOptTM related significantly to the max aorta VTI (AVTI) by Echo, the concordance correlation coefficient (CCC) was so high from 0.96 to 0.99. But up to now, there are no clinical trials to evaluate mid-long term clinical outcome for CRTP/D patients by QuickOptTM and Echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.
Interventions
DEVICECardiac Resynchronization Therapy
Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
DEVICEOptimization using echocardiography
Optimization of the AV/PV and VV delays using echocardiography
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline | Baseline and12 months | The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| QuickOpt Group Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation. | 198 |
| Echocardiography Group Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography | 194 |
| Total | 392 |
Baseline characteristics
| Characteristic | Echocardiography Group | QuickOpt Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 61 Participants | 77 Participants | 138 Participants |
| Age, Categorical Between 18 and 65 years | 133 Participants | 121 Participants | 254 Participants |
| Age, Continuous | 59.21 years STANDARD_DEVIATION 11.36 | 61.38 years STANDARD_DEVIATION 11.77 | 60.17 years STANDARD_DEVIATION 11.62 |
| Region of Enrollment China | 194 participants | 198 participants | 392 participants |
| Sex: Female, Male Female | 54 Participants | 49 Participants | 103 Participants |
| Sex: Female, Male Male | 140 Participants | 149 Participants | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 198 | 15 / 194 |
| other Total, other adverse events | 6 / 198 | 6 / 194 |
| serious Total, serious adverse events | 28 / 198 | 19 / 194 |
Outcome results
Primary
Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline
The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.
Time frame: Baseline and12 months
Population: A total of 108 patients in the QuickOpt group and 118 patients in the Echocardiography group had LVESV measurements at both baseline and 12 months to allow comparison of the percent change in LVESV.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QuickOpt Group | Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline | -24.69 Percent change in LVESV | Standard Deviation 33.86 |
| Echocardiography Group | Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline | -25.13 Percent change in LVESV | Standard Deviation 36.06 |