| Primary | Electrical Synchronization Response | Standard Deviation of Activation Times (SDAT) is a measurement of dyssynchrony, taken by the ECG belt. As described in the SDAT Acute Protocol (below) and intervention sections, percent change in SDAT from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval. | Subjects with SDAT measurements available for each pacing configuration. | Posted | | Mean | 95% Confidence Interval | Difference in percent change in SDAT | | At implant during acute protocol | | | | ID | Title | Description |
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| OG000 | SDAT Acute Protocol | For each intervention, data from 9 sections of atrial only pacing and intervention will be used, beginning with the atrial-only pacing that immediately precedes the first intervention section and ending with the atrial-only pacing immediately following the last intervention pacing section. The SDAT measurement will be taken during one of the 4 intervention pacing sections and one of the 5 atrial-only pacing sections. This will provide 1 pair of SDAT measurements for each patient-intervention combination. For each pair, the percent change from the atrial-only section to the intervention section will be computed. Within each patient, the percent changes calculated from the 5 AV delay settings (default, default + 30ms, default + 60ms, default - 30ms, default - 60ms) will be used to fit a quadratic curve. The minimum value from the fitted quadratic curve within the delay settings will be used as the SDAT measurement for that patient-pacing configuration combination. |
| | | Title | Denominators | Categories |
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| CSPOT vs CSP | | | Title | Measurements |
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| - OG00015.18(4.26 to 26.09)
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| | CSPOT vs BiV | | | Title | Measurements |
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| - OG00017.04(4.32 to 29.76)
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| Primary | Hemodynamic Response | Left Ventricular (LV) dP/dt max, a measurement of the initial velocity of myocardial contraction. As described in the LV dP/dt max (below) and intervention sections, percent change in LV dP/dt max from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval. | Subjects with LV dP/dt max measurements available for each pacing configuration | Posted | | Mean | 95% Confidence Interval | Difference in % change LV dP/dt max | | At implant during acute protocol | | | | ID | Title | Description |
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| OG000 | LV dP/dt Max Acute Protocol | For each intervention, data from 9 sections of atrial only pacing and intervention will be used, beginning with the atrial-only pacing that immediately precedes the first intervention section and ending with the atrial-only pacing immediately following the last intervention pacing section. For each of the nine sections, the section will be split into the "first half" and "second half". For each half section, the median of the LV dP/dt max values for beats within the defined period will be calculated. This will provide eight pairs of medians from adjacent atrial-only pacing and intervention-delay setting combination sections. For each pair, the percent change from the atrial-only section median to the intervention section median will be computed. This will be repeated for each delay setting described in the intervention section. Within each patient, the median percent changes calculated from the 5 AV delay settings (default, default + 30ms, default + 60ms, default - 30ms, default - 60ms) will be used to fit a quadratic curve. The maximum value from the fitted quadratic curve within the delay settings will be used as the LV dP/dt max measurement for that patient-pacing configuration combination. |
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| Secondary | Left Ventricular Ejection Fraction (LVEF) | Left ventricular ejection fraction will be measured, based on echocardiography, at the baseline visit and again at the 6-month follow-up visit. Change will be calculated as the value observed at baseline subtracted from the value observed at 6 months. | Subjects with LVEF measurements at both baseline and 6-month follow-up visit | Posted | | Mean | 95% Confidence Interval | Change in percentage of LVEF | | Baseline and 6 months | | | | ID | Title | Description |
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| OG000 | Single Arm | Patients will undergo 1) Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then the 2) acute pacing protocol, and then 3) device implant. During the acute pacing protocol (step 2), all patients will undergo three types of pacing configurations and for each pacing configuration several delay settings, as defined in Assigned Interventions. For each intervention, defined as a unique combination of pacing configuration and delay setting, the protocol will alternate for several heartbeats between AV pacing and intervention (5 sections of AV pacing and 4 sections of intervention). For each set of 9, Left Ventricular dP/dt max will be calculated continuously, and Standard Deviation of Activation Time will be selected from one of the sections for atrial-only pacing and one of the intervention sections. Device implant (step 3) will be with either a CRT-D or CRT-P. Each patient's device will be programmed to CSPOT pacing. Patients will be followed for 6 months. |
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| Secondary | Left Ventricular End Systolic Volume (LVESV) | Left ventricular end systolic volume will be measured, based on echocardiography, at the baseline visit and again at the 6-month follow-up visit. The change will be calculated as difference between the 6-month and baseline values, divided by the baseline value. | Subjects who had LVESV recorded at both baseline and the 6-month follow-up visit | Posted | | Mean | 95% Confidence Interval | percent change lvesv | | Baseline and 6 months | | | | ID | Title | Description |
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| OG000 | Single Arm | Patients will undergo 1) Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then the 2) acute pacing protocol, and then 3) device implant. During the acute pacing protocol (step 2), all patients will undergo three types of pacing configurations and for each pacing configuration several delay settings, as defined in Assigned Interventions. For each intervention, defined as a unique combination of pacing configuration and delay setting, the protocol will alternate for several heartbeats between AV pacing and intervention (5 sections of AV pacing and 4 sections of intervention). For each set of 9, Left Ventricular dP/dt max will be calculated continuously, and Standard Deviation of Activation Time will be selected from one of the sections for atrial-only pacing and one of the intervention sections. Device implant (step 3) will be with either a CRT-D or CRT-P. Each patient's device will be programmed to CSPOT pacing. Patients will be followed for 6 months. |
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| Secondary | Clinical Composite Score (CCS) | The Clinical Composite Score (CCS) is a validated 3-level categorical variable that can take the values - Improved, Unchanged, or Worsened - at each follow-up visit. It is based on mortality, HF events, termination of device function, NYHA score, and patient global assessment. Briefly, the scoring system is as follows:
- A patient is considered "worsened" if they die, demonstrate a worsened NYHA class, report at least moderately worsened heart-failure symptoms, or are hospitalized or permanently discontinue therapy because of or associated with worsening heart-failure
- A patient is considered "improved" if they have not "worsened" and either demonstrate improvement in NYHA class or report at least moderately improved heart-failure symptoms
- A patient is considered "stabilized" if they have not "worsened" or "improved"
- A patient is considered "unavailable" if they did not complete 6-month visit and was not "worsened"
| Subjects who had a successful implant procedure. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Single Arm | Patients will undergo 1) Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then the 2) acute pacing protocol, and then 3) device implant. During the acute pacing protocol (step 2), all patients will undergo three types of pacing configurations and for each pacing configuration several delay settings, as defined in Assigned Interventions. For each intervention, defined as a unique combination of pacing configuration and delay setting, the protocol will alternate for several heartbeats between AV pacing and intervention (5 sections of AV pacing and 4 sections of intervention). For each set of 9, Left Ventricular dP/dt max will be calculated continuously, and Standard Deviation of Activation Time will be selected from one of the sections for atrial-only pacing and one of the intervention sections. Device implant (step 3) will be with either a CRT-D or CRT-P. Each patient's device will be programmed to CSPOT pacing. Patients will be followed for 6 months. |
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| Secondary | Absolute Percent Change in SDAT by QRS Subgroup | Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) by baseline QRS subgroup for each pacing configuration CSP, BiV, CSPOT during acute protocol at implant. The QRS subgroups were subjects with QRS width greater than 171ms and QRS width less than or equal to 171ms as measured by 12-lead ECG | Subjects who had SDAT measured during the acute protocol. | Posted | | Mean | 95% Confidence Interval | abs percent change in SDAT | | At Implant during acute protocol | | | | ID | Title | Description |
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| OG000 | QRS Greater Than 171ms | Subjects who completed acute protocol with QRS width greater than 171ms as measured by 12-lead ECG. SDAT | | OG001 | QRS Less Than or Equal to 171ms | Subjects who completed acute protocol with QRS width less than or equal to 171ms as measured by 12-lead ECG |
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| Secondary | Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders | Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) split by subjects with pure Left Bundle Branch Block (LBBB) and with other Conduction Disorders for each pacing configuration CSP, BiV and CSPOT during acute protocol. | Subjects who had SDAT measured during the acute protocol. | Posted | | Mean | 95% Confidence Interval | abs percent change in SDAT | | At Implant during acute protocol | | | | ID | Title | Description |
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| OG000 | LBBB | Subjects who completed acute protocol and had pure Left Bundle Branch Block | | OG001 | NIVCD | Subjects who completed acute protocol who had conduction disorder other than pure Left Bundle Branch Block |
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| Secondary | Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | Absolute Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) split by subjects with Ischemic Cardiomyopathy and those with Non-Ischemic Cardiomyopathy for each pacing configuration CSP, BiV and CSPOT during acute protocol. | Subjects who had SDAT measured during the acute protocol. | Posted | | Mean | 95% Confidence Interval | abs percent change in SDAT | | At Implant during acute protocol | | | | ID | Title | Description |
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| OG000 | Non-Ischemic | Subjects who completed acute protocol and had Non-Ischemic Cardiomyopathy | | OG001 | Ischemic | Subjects who completed acute protocol who had Ischemic Cardiomyopathy |
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| Secondary | Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description)split by subjects with Ischemic Cardiomyopathy and those with Non-Ischemic Cardiomyopathy for each pacing configuration CSP, BiV and CSPOT during acute protocol. | Subjects who had LV dP/dt max measured during acute protocol | Posted | | Mean | 95% Confidence Interval | percent change in LV dP/dt max | | At Implant during acute protocol | | | | ID | Title | Description |
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| OG000 | Non-Ischemic | Subjects who completed acute protocol and had Non-Ischemic Cardiomyopathy | | OG001 | Ischemic | Subjects who completed acute protocol who had Ischemic Cardiomyopathy |
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| Secondary | Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD) | Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description) split by subjects with pure Left Bundle Branch Block (LBBB) and with other Conduction Disorders (NIVCD) for each pacing configuration CSP, BiV and CSPOT during acute protocol | Subjects who had LV dP/dt max measured during acute protocol | Posted | | Mean | 95% Confidence Interval | percent change in LV dP/dt max | | At Implant during acute protocol | | | | ID | Title | Description |
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| OG000 | LBBB | Subjects who completed acute protocol and had pure Left Bundle Branch Block | | OG001 | NIVCD | Subjects who completed acute protocol who had conduction disorder other than pure Left Bundle Branch Block |
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| Secondary | Improvement in LV dP/dt Max by QRS Subgroup | Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description) by QRS subgroup for each pacing configuration CSP, BiV and CSPOT during acute protocol. The QRS subgroups were subjects with QRS width greater than 171ms and QRS width less than or equal to 171ms as measured by 12-lead ECG | Subjects who had LV dP/dt max measured during acute protocol | Posted | | Mean | 95% Confidence Interval | percent change in LV dP/dt max | | At Implant during acute protocol | | | | ID | Title | Description |
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| OG000 | QRS Greater Than 171ms | Subjects who completed acute protocol with QRS width greater than 171ms as measured by 12-lead ECG | | OG001 | QRS Less Than or Equal to 171ms | Subjects who completed acute protocol with QRS width less than or equal to 171ms as measured by 12-lead ECG |
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