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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quickopt Group | Experimental | the QuickOpt Group patients will be optimized by QuickOpt(IEGM); |
|
| Echocardiography group | Active Comparator | the Echo Group patients will be optimized by Echo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and12 months |
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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
Exclusion Criteria:
• Patient has limited intrinsic atrial activity (≤ 40 bpm)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | Beijing Municipality | 100037 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quickopt Group | the QuickOpt Group patients will be optimized by QuickOpt(IEGM); Cardiac 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. |
| FG001 | Echocardiography Group | the Echo Group patients will be optimized by Echo. Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Echocardiography Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Percent change in LVESV | Baseline and12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quickopt Group | the QuickOpt Group patients will be optimized by QuickOpt(IEGM); Cardiac 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment | Death; not related to study devices |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phrenic nerve stimulation | Cardiac disorders | Non-systematic Assessment | Patient experience phrenic nerve stimulation. The event is not related to study devices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clay Cohorn, Program Director | CRT, Global Clinical Affairs, Cardiac Arrhythmias and Heart Failure, Abbott Medical Devices | +1 972 309 8087 | clay.cohorn@abbott.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Optimization using echocardiography | Device | Optimization of the AV/PV and VV delays using echocardiography |
|
Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
| OG001 | Echocardiography Group | Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography |
|
|
| 23 |
| 198 |
| 28 |
| 198 |
| 6 |
| 198 |
| EG001 | Echocardiography Group | the Echo Group patients will be optimized by Echo. Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography | 15 | 194 | 19 | 194 | 6 | 194 |
|
| Hopitalization | Cardiac disorders | Non-systematic Assessment | Patient hopitalized then expired; death not related to study devices |
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| Heart Failure Deterioration; Death | Cardiac disorders | Non-systematic Assessment | Heart failure deteriorated; patient expired; SAE not related to study devices. |
|
| Cardiopulmonary arrest, death | Cardiac disorders | Non-systematic Assessment | Patient sustained cardiopulmonary arrest. Patient expired. The death is not related to study devices. |
|
| Junctional rhythm, hypotension | Cardiac disorders | Non-systematic Assessment | Patient sustained junctional rhythm and low blood pressure. The event was considered related to study device. The pace maker was re-interrogated. |
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| Heart failure deterioration, hospitalization | Cardiac disorders | Non-systematic Assessment | Heart failure deteriorated. Patient hospitalized. The event is not related to study devices. |
|
| Heart failure deterioration, elevated left ventricular pacing threshold | Cardiac disorders | Non-systematic Assessment | Heart failure deteriorated. Left ventricular pacing threshold increased. The event is not related to study devices. |
|
| Heart failure deterioration, myocardial infarction, venous thrombosis, death | Cardiac disorders | Non-systematic Assessment | Heart failure deteriorated. Patient sustained myocardial infarction and venous thrombosis. Patient expired. The death is not related to study devices. |
|
| Heart failure deterioration, phrenic nerve stimulation | Cardiac disorders | Non-systematic Assessment | Heart failure deteriorated. Patient experienced phrenic nerve stimulation. The event was considered related to study devices. |
|
| Myocardial ischemia, staged heart bypass surgery | Cardiac disorders | Non-systematic Assessment | Patient was diagnosed with myocardial ischemia and underwent staged heart bypass surgery. The event is not related to study devices. |
|
| Chest distress, short breaths | Cardiac disorders | Non-systematic Assessment | Patient stated chest distress and short breaths. Patient was hospitalized. The event is not related to study devices. |
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| Cerebral hemorrhage, death | Vascular disorders | Non-systematic Assessment | Patient sustained cerebral hemorrhage. Patient expired. The death is not related to study devices. |
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| Haematoma, low right atrial lead sensing | Cardiac disorders | Non-systematic Assessment | Patient sustained haematoma; the right atrial lead sensing decreased. The event is not related to study devices. |
|
| pacemaker pocket ulceration | Cardiac disorders | Non-systematic Assessment | Pacemaker pocket skin ulceration. The event is not related to study devices. |
|
| pacemaker reject | Cardiac disorders | Non-systematic Assessment | Patient's body rejected pacemaker. The event is not related to study devices. |
|
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| Elevated left ventricular pacing threshold | Cardiac disorders | Non-systematic Assessment | Left ventricular pacing threshold increased. |
|
| Coronary sinus dissection | Cardiac disorders | Non-systematic Assessment | Patient sustained coronary sinus dissection; the event is not related to study devices. |
|
| Right ventricular lead dislocation/displacement | Cardiac disorders | Non-systematic Assessment | Right ventricular lead dislocation/displacement; the event is not related to study devices. |
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| Right atrial lead dislocation/displacement | Cardiac disorders | Non-systematic Assessment | Right atrial lead dislocation/displacement; the event is not related to study devices. |
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| Left ventricular lead dislocation/displacement | Cardiac disorders | Non-systematic Assessment | Left ventricular lead dislocation/displacement; the event is related to study devices. |
|
| Elevated pacing threshold of left ventricular lead; lead dislocation/displacem | Cardiac disorders | Non-systematic Assessment | Elevated pacing threshold of left ventricular lead; lead dislocation/displacem; the event is related to study devices. |
|
| Infection at pacing system | Infections and infestations | Non-systematic Assessment | Patient sustain infection at pacing system; the event is not related to study devices. |
|
| Anaphylactic shock | Immune system disorders | Non-systematic Assessment | Patient experienced anaphylactic shock; the event is not related to study devices. |
|
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