Trial Outcomes & Findings for Left Ventricular MultiSpot Pacing for CRT (iSPOT) (NCT NCT01883141)
NCT ID: NCT01883141
Last Updated: 2025-07-02
Results Overview
Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multispot LV pacing configuration compared to normal biventricular pacing in patients undergoing a research study, an electrophysiological exploratory procedure or cardiac resynchronization therapy (CRT) implant. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\[median dP/dt max during pacing On\] - (median baseline dP/dt max during pacing Off\])/\[median dP/dt max during pacing Off\]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.
COMPLETED
NA
31 participants
Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
2025-07-02
Participant Flow
Participant milestones
| Measure |
Enrolled Patients
Patients who signed informed consent
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
Passing Eligibility
|
30
|
|
Overall Study
EP Study Performed
|
30
|
|
Overall Study
Usable EP Data
|
26
|
|
Overall Study
BiV Pacing-Distal
|
24
|
|
Overall Study
BiV Pacing-Mid
|
25
|
|
Overall Study
BiV Pacing-Standard Therapy
|
26
|
|
Overall Study
Multispot-pacing
|
24
|
|
Overall Study
BiV Pacing-Anterior
|
23
|
|
Overall Study
Biv Pacing-Posterior
|
22
|
|
Overall Study
Multivein
|
23
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Left Ventricular MultiSpot Pacing for CRT (iSPOT)
Baseline characteristics by cohort
| Measure |
Eligible Patients
n=30 Participants
The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
|
|---|---|
|
Age, Continuous
|
61 Years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hoursPopulation: Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BiV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis (EP data collection issues: n = 4).
Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multispot LV pacing configuration compared to normal biventricular pacing in patients undergoing a research study, an electrophysiological exploratory procedure or cardiac resynchronization therapy (CRT) implant. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\[median dP/dt max during pacing On\] - (median baseline dP/dt max during pacing Off\])/\[median dP/dt max during pacing Off\]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.
Outcome measures
| Measure |
Eligible Patients
n=26 Participants
The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
|
|---|---|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV distal
|
28.38 percentage change LV dP/dt max
Standard Error 3.15
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV mid
|
28.58 percentage change LV dP/dt max
Standard Error 2.62
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV proximal
|
30.05 percentage change LV dP/dt max
Standard Error 2.75
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
Multispot
|
31.04 percentage change LV dP/dt max
Standard Error 3.25
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV anterior
|
22.17 percentage change LV dP/dt max
Standard Error 2.31
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV posterior
|
30.05 percentage change LV dP/dt max
Standard Error 3.7
|
SECONDARY outcome
Timeframe: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hoursPopulation: Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BiV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis (EP data collection issues: n = 4).
Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multi-vein LV pacing configuration compared to normal biventricular pacing in patients undergoing a research study, an electrophysiological exploratory procedure or CRT-implant. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\[median dP/dt max during pacing On\] - (median baseline dP/dt max during pacing Off\])/\[median dP/dt max during pacing Off\]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.
Outcome measures
| Measure |
Eligible Patients
n=26 Participants
The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
|
|---|---|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV distal
|
28.38 percentage change LV dP/dt max
Standard Error 3.15
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV mid
|
28.58 percentage change LV dP/dt max
Standard Error 2.62
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV proximal
|
30.05 percentage change LV dP/dt max
Standard Error 2.75
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV anterior
|
22.17 percentage change LV dP/dt max
Standard Error 2.31
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing
BiV posterior
|
30.05 percentage change LV dP/dt max
Standard Error 3.7
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing
Multivein
|
30.83 percentage change LV dP/dt max
Standard Error 3.44
|
SECONDARY outcome
Timeframe: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hoursPopulation: Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BiV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis (EP data collection issues: n = 4).
Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multi-vein LV pacing configuration compared to multispot LV pacing in patients undergoing a research study, an electrophysiological exploratory procedure or CRT-implant. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\[median dP/dt max during pacing On\] - (median baseline dP/dt max during pacing Off\])/\[median dP/dt max during pacing Off\]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.
Outcome measures
| Measure |
Eligible Patients
n=26 Participants
The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
|
|---|---|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Multispot LV Pacing Configuration
Multispot
|
31.04 percentage change LV dP/dt max
Standard Error 3.25
|
|
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Multispot LV Pacing Configuration
Multivein
|
30.83 percentage change LV dP/dt max
Standard Error 3.44
|
SECONDARY outcome
Timeframe: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hoursPopulation: Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BIV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis due to EP data collection issues.
Correlate blood pressure, EGMs and electrocardiographic mapping measurements with the percentage change LV dP/dt max values obtained during each of the three pacing configurations BiV (BiV distal, BiV mid, BiV proximal, BiV anterior, BiV posterior), MultiVein and MultiSpot. Correlation will be summarized over all pacing configurations and time points since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration or per time point. A linear mixed effects models as described in Roy, Biometrical Journal 48 (2006) 2, 286- 301 was used for the diastolic and systolic blood pressures. Due to the convergence problems for the linear mixed for Q-LV and QRS, the general linear model as described in Blank \& Altman, Biometrical Journal 310 (1995), p 446, was used for Q-LV and QRS.
Outcome measures
| Measure |
Eligible Patients
n=26 Participants
The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
|
|---|---|
|
Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values
Systolic blood pressure (Codan System)
|
0.63 Correlation coefficient
|
|
Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values
Diastolic blood pressure (Codan system)
|
0.45 Correlation coefficient
|
|
Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values
Systolic blood pressure (Nexfin system)
|
0.37 Correlation coefficient
|
|
Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values
Diastolic blood pressure (Nexfin system)
|
0.23 Correlation coefficient
|
|
Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values
QRS duration ratio
|
-0.20 Correlation coefficient
|
|
Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values
Q-LV
|
0.52 Correlation coefficient
|
SECONDARY outcome
Timeframe: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hoursPopulation: From the 30 eligible patients, 4 patients were excluded from analysis due to EP data collection issues and 2 patients were excluded since no blood pressure was collected non-invasively using a Nexfin system.
Evaluate whether the non-invasive measurements (Nexfin blood pressures) that are also collected during the study can identify the pacing configuration with the highest percentage change LV dP/dt max. For each patient and all time points of data collection, a regression analysis was applied to determine the highest predicted percentage change LV dP/dtmax or percentage change Nexfin pressure per configuration. The Kappa statistic was then determined based on a 7x7 contingency table where the rows and columns corresponded to the pacing configurations. There is no interest in determining the agreement statistics Kappa per time point or per configuration since the interest of this analysis is in the overall agreement between LV dP/dt max and non-invasive measurements.
Outcome measures
| Measure |
Eligible Patients
n=24 Participants
The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
|
|---|---|
|
Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max
Systolic blood pressure (Nexfin system)
|
0.33 Kappa statistic
Interval 0.09 to 0.58
|
|
Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max
Diastolic blood pressure (Nexfin system)
|
0.33 Kappa statistic
Interval 0.09 to 0.56
|
SECONDARY outcome
Timeframe: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hoursPopulation: Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BIV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis due to EP data collection issues.
Evaluate the within patient variability in positive LV dP/dt max measurements. The standard deviation of the percentage change LV dP/dt max between pacing configurations will be evaluated to obtain information for future sample size calculations for the primary outcome.The standard deviation is summarized over all available subjects and could be used as an estimate of within patient variability for future sample size calculations for the primary outcome.
Outcome measures
| Measure |
Eligible Patients
n=26 Participants
The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria.
|
|---|---|
|
Within Patient Variability in Positive LV dP/dt Max
Multispot to BiV distal
|
7.9 percentage change
|
|
Within Patient Variability in Positive LV dP/dt Max
MultiSpot to BiV proximal
|
5.6 percentage change
|
|
Within Patient Variability in Positive LV dP/dt Max
MultiSpot to BiV mid
|
7.1 percentage change
|
|
Within Patient Variability in Positive LV dP/dt Max
MultiSpot to BiV anterior
|
11.0 percentage change
|
|
Within Patient Variability in Positive LV dP/dt Max
MultiSpot to BiV posterior
|
13.5 percentage change
|
Adverse Events
Enrolled Patients
Serious adverse events
| Measure |
Enrolled Patients
n=31 participants at risk
Patients who signed informed consent
|
|---|---|
|
Vascular disorders
Shock haemorrhagic
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from enrollment to study exit. All types of adverse events (not only cardiovascular) were collected. Median number of days between enrollment and exit was 8 days with a minimum of 0 and a maximum of 116 days.
|
|
General disorders
Lead dislodgement
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from enrollment to study exit. All types of adverse events (not only cardiovascular) were collected. Median number of days between enrollment and exit was 8 days with a minimum of 0 and a maximum of 116 days.
|
|
Infections and infestations
Appendicitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from enrollment to study exit. All types of adverse events (not only cardiovascular) were collected. Median number of days between enrollment and exit was 8 days with a minimum of 0 and a maximum of 116 days.
|
|
Cardiac disorders
Cardiac failure
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from enrollment to study exit. All types of adverse events (not only cardiovascular) were collected. Median number of days between enrollment and exit was 8 days with a minimum of 0 and a maximum of 116 days.
|
|
Injury, poisoning and procedural complications
Venous injury
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from enrollment to study exit. All types of adverse events (not only cardiovascular) were collected. Median number of days between enrollment and exit was 8 days with a minimum of 0 and a maximum of 116 days.
|
|
Cardiac disorders
Atrial flutter
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from enrollment to study exit. All types of adverse events (not only cardiovascular) were collected. Median number of days between enrollment and exit was 8 days with a minimum of 0 and a maximum of 116 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from enrollment to study exit. All types of adverse events (not only cardiovascular) were collected. Median number of days between enrollment and exit was 8 days with a minimum of 0 and a maximum of 116 days.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60