An interventional study of Cardiac Resynchronization Therapy and Optimization using echocardiography in Heart Failure, sponsored by Abbott Medical Devices. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment
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。
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 400 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system
Exclusion Criteria:
Patient has limited intrinsic atrial activity (≤ 40 bpm)
the QuickOpt Group patients will be optimized by QuickOpt(IEGM);
Device: Cardiac Resynchronization Therapy
the Echo Group patients will be optimized by Echo.
Device: Optimization using echocardiography
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.
Optimization of the AV/PV and VV delays using echocardiography
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
| Milestone | Quickopt Group | Echocardiography Group |
|---|---|---|
| Started | 200 | 200 |
| Completed | 153 | 163 |
| Not completed | 47 | 37 |
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.
| Percent change in LVESV | QuickOpt Group | Echocardiography Group |
|---|---|---|
| Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline | -24.69 ± 33.86 | -25.13 ± 36.06 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quickopt Group | 23/198 (11.6%) | 28/198 (14.1%) | 6/198 (3%) |
| Echocardiography Group | 15/194 (7.7%) | 19/194 (9.8%) | 6/194 (3.1%) |
| Event | Quickopt Group | Echocardiography Group |
|---|---|---|
| DeathCardiac disorders | 15/198 | 13/194 |
| HopitalizationCardiac disorders | 3/198 | 1/194 |
| Heart Failure Deterioration; DeathCardiac disorders | 2/198 | 0/194 |
| Cardiopulmonary arrest, deathCardiac disorders | 2/198 | 0/194 |
| Heart failure deterioration, hospitalizationCardiac disorders | 0/198 | 1/194 |
| Heart failure deterioration, phrenic nerve stimulationCardiac disorders | 0/198 | 1/194 |
| Myocardial ischemia, staged heart bypass surgeryCardiac disorders | 0/198 | 1/194 |
| Cerebral hemorrhage, deathVascular disorders | 0/198 | 1/194 |
| Haematoma, low right atrial lead sensingCardiac disorders | 0/198 | 1/194 |
| Junctional rhythm, hypotensionCardiac disorders | 1/198 | 0/194 |
| Event | Quickopt Group | Echocardiography Group |
|---|---|---|
| Phrenic nerve stimulationCardiac disorders | 1/198 | 2/194 |
| Elevated left ventricular pacing thresholdCardiac disorders | 2/198 | 0/194 |
| Right atrial lead dislocation/displacementCardiac disorders | 0/198 | 1/194 |
| Elevated pacing threshold of left ventricular lead; lead dislocation/displacemCardiac disorders | 0/198 | 1/194 |
| Infection at pacing systemInfections and infestations | 0/198 | 1/194 |
| Anaphylactic shockImmune system disorders | 0/198 | 1/194 |
| Coronary sinus dissectionCardiac disorders | 1/198 | 0/194 |
| Right ventricular lead dislocation/displacementCardiac disorders | 1/198 | 0/194 |
| Left ventricular lead dislocation/displacementCardiac disorders | 1/198 | 0/194 |
| Age, Categorical(Participants) | QuickOpt Group | Echocardiography Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 121 | 133 | 254 |
| >=65 years | 77 | 61 | 138 |
| Age, Continuous(years) | QuickOpt Group | Echocardiography Group | Total |
|---|---|---|---|
| Mean | 61.38 ± 11.77 | 59.21 ± 11.36 | 60.17 ± 11.62 |
| Sex: Female, Male(Participants) | QuickOpt Group | Echocardiography Group | Total |
|---|---|---|---|
| Female | 49 | 54 | 103 |
| Male | 149 | 140 | 289 |
| Region of Enrollment(participants) | QuickOpt Group | Echocardiography Group | Total |
|---|---|---|---|
| China | 198 | 194 | 392 |
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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