Heart Failure
Conditions
Brief summary
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.
Interventions
DEVICELeft ventricular coronary sinus (BiV) configuration
For subjects with a pacemaker, pacing of the left ventricular coronary sinus only. For subjects with a defibrillator, biventricular pacing of the left ventricular coronary sinus and the right ventricle. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay. Patients with a defibrillator will receive two additional delays LV precedes default by 30ms and LV precedes default by 60ms.
DEVICEConduction system pacing-only configuration
Conduction System Pacing (CSP) of the left bundle branch. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, and default - 60ms AV delay.
DEVICEConduction System Pacing Optimized Therapy (CSPOT) configuration
A combination of Left Ventricle pacing and Conduction System Pacing of the left bundle branch. During the acute protocol, the eight delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay, CSP precedes default by 30ms, LV precedes default by 30ms and LV precedes default by 60ms.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is willing and able to provide written informed consent * Subject is at least 18 years of age * Patient is willing and able to comply with the protocol, including follow-up visits * The patient's medical records must be accessible by the enrolling site over the follow-up period * Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria. * De-novo CRT implant, including upgrade from pacemaker or ICD
Exclusion criteria
* Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter) * Subject has 2nd or 3rd degree AV (Atrioventricular) Block * Subject has RBBB with no additional conduction block * Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms * Subject experienced MI within 40 days prior to enrollment * Subject underwent valve surgery, within 90 days prior to enrollment * Subject is post heart transplantation or is actively listed on the transplantation list * Subject is implanted with a LV assist device * Subject has severe renal disease * Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure * Subject has severe aortic stenosis (with a valve area of \<1.0 cm or significant valve disease expected to be operated within study period) * Subject has severe aortic calcification or severe peripheral arterial disease * Subject has complex and uncorrected congenital heart disease * Subject has mechanical heart valve * Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence) * Subject is enrolled in another study that could confound the results of this study without documented pre-approval from Medtronic study manager
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrical Synchronization Response | At implant during acute protocol | 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. |
| Hemodynamic Response | At implant during acute protocol | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Composite Score (CCS) | 6 months | 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 |
| Absolute Percent Change in SDAT by QRS Subgroup | At Implant during acute protocol | 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 |
| Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders | At Implant during acute protocol | 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. |
| Left Ventricular Ejection Fraction (LVEF) | Baseline and 6 months | 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. |
| Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | At Implant during acute protocol | 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. |
| Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD) | At Implant during acute protocol | 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 |
| Improvement in LV dP/dt Max by QRS Subgroup | At Implant during acute protocol | 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 |
| Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | At Implant during acute protocol | 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. |
| Left Ventricular End Systolic Volume (LVESV) | Baseline and 6 months | 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. |
Countries
Ireland, Poland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Screen Failure | 2 |
| Overall Study | Unsuccessful Procedure | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 11.1 |
| Diastolic Blood Pressure | 70.8 mm Hg STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 39 Participants |
| Height | 171.1 cm STANDARD_DEVIATION 10.5 |
| NYHA Classification Class I | 5 Participants |
| NYHA Classification Class II | 29 Participants |
| NYHA Classification Class III | 24 Participants |
| NYHA Classification Class IV | 1 Participants |
| NYHA Classification Not Available | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 36 Participants |
| Systolic Blood Pressure | 121.9 mm Hg STANDARD_DEVIATION 17.5 |
| Weight | 88.2 kg STANDARD_DEVIATION 18.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 60 |
| other Total, other adverse events | 14 / 60 |
| serious Total, serious adverse events | 20 / 60 |
Outcome results
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.
Time frame: At implant during acute protocol
Population: Subjects with SDAT measurements available for each pacing configuration.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SDAT Acute Protocol | Electrical Synchronization Response | CSPOT vs CSP | 15.18 Difference in percent change in SDAT |
| SDAT Acute Protocol | Electrical Synchronization Response | CSPOT vs BiV | 17.04 Difference in percent change in SDAT |
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.
Time frame: At implant during acute protocol
Population: Subjects with LV dP/dt max measurements available for each pacing configuration
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SDAT Acute Protocol | Hemodynamic Response | CSPOT vs CSP | 10.33 Difference in % change LV dP/dt max |
| SDAT Acute Protocol | Hemodynamic Response | CSPOT vs BiV | -1.31 Difference in % change LV dP/dt max |
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
Time frame: At Implant during acute protocol
Population: Subjects who had SDAT measured during the acute protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SDAT Acute Protocol | Absolute Percent Change in SDAT by QRS Subgroup | CSPOT | 42.77 abs percent change in SDAT |
| SDAT Acute Protocol | Absolute Percent Change in SDAT by QRS Subgroup | BIV | 34.61 abs percent change in SDAT |
| SDAT Acute Protocol | Absolute Percent Change in SDAT by QRS Subgroup | CSP | 34.26 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT by QRS Subgroup | CSPOT | 42.46 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT by QRS Subgroup | BIV | 19.72 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT by QRS Subgroup | CSP | 22.05 abs percent change in SDAT |
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.
Time frame: At Implant during acute protocol
Population: Subjects who had SDAT measured during the acute protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SDAT Acute Protocol | Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | CSP | 38.83 abs percent change in SDAT |
| SDAT Acute Protocol | Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | CSPOT | 48.96 abs percent change in SDAT |
| SDAT Acute Protocol | Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | BIV | 36.95 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | CSP | 2.23 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | CSPOT | 28.95 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | BIV | 3.74 abs percent change in SDAT |
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.
Time frame: At Implant during acute protocol
Population: Subjects who had SDAT measured during the acute protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SDAT Acute Protocol | Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders | CSPOT | 51.47 abs percent change in SDAT |
| SDAT Acute Protocol | Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders | BIV | 36.28 abs percent change in SDAT |
| SDAT Acute Protocol | Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders | CSP | 40.18 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders | CSPOT | 38.01 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders | BIV | 21.31 abs percent change in SDAT |
| QRS Less Than or Equal to 171ms | Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders | CSP | 20.28 abs percent change in SDAT |
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
Time frame: 6 months
Population: Subjects who had a successful implant procedure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SDAT Acute Protocol | Clinical Composite Score (CCS) | Improved | 35 Participants |
| SDAT Acute Protocol | Clinical Composite Score (CCS) | Stabilized | 2 Participants |
| SDAT Acute Protocol | Clinical Composite Score (CCS) | Worsened | 6 Participants |
| SDAT Acute Protocol | Clinical Composite Score (CCS) | Unavailable | 3 Participants |
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
Time frame: At Implant during acute protocol
Population: Subjects who had LV dP/dt max measured during acute protocol
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SDAT Acute Protocol | Improvement in LV dP/dt Max by QRS Subgroup | CSPOT | 29.28 percent change in LV dP/dt max |
| SDAT Acute Protocol | Improvement in LV dP/dt Max by QRS Subgroup | BIV | 32.18 percent change in LV dP/dt max |
| SDAT Acute Protocol | Improvement in LV dP/dt Max by QRS Subgroup | CSP | 18.2 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Improvement in LV dP/dt Max by QRS Subgroup | CSPOT | 22.77 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Improvement in LV dP/dt Max by QRS Subgroup | CSP | 14.49 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Improvement in LV dP/dt Max by QRS Subgroup | BIV | 20.88 percent change in LV dP/dt max |
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.
Time frame: Baseline and 6 months
Population: Subjects with LVEF measurements at both baseline and 6-month follow-up visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SDAT Acute Protocol | Left Ventricular Ejection Fraction (LVEF) | 15.24 Change in percentage of LVEF |
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.
Time frame: Baseline and 6 months
Population: Subjects who had LVESV recorded at both baseline and the 6-month follow-up visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SDAT Acute Protocol | Left Ventricular End Systolic Volume (LVESV) | -43.28 percent change lvesv |
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.
Time frame: At Implant during acute protocol
Population: Subjects who had LV dP/dt max measured during acute protocol
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SDAT Acute Protocol | Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | CSPOT | 30.05 percent change in LV dP/dt max |
| SDAT Acute Protocol | Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | BIV | 30.64 percent change in LV dP/dt max |
| SDAT Acute Protocol | Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | CSP | 20.03 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | CSPOT | 17.56 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | CSP | 8.32 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy | BIV | 17.62 percent change in LV dP/dt max |
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
Time frame: At Implant during acute protocol
Population: Subjects who had LV dP/dt max measured during acute protocol
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SDAT Acute Protocol | Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD) | CSPOT | 28.08 percent change in LV dP/dt max |
| SDAT Acute Protocol | Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD) | BIV | 29.35 percent change in LV dP/dt max |
| SDAT Acute Protocol | Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD) | CSP | 18.02 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD) | CSPOT | 24.59 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD) | BIV | 24.65 percent change in LV dP/dt max |
| QRS Less Than or Equal to 171ms | Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD) | CSP | 15.29 percent change in LV dP/dt max |