Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the iSPOT Study is to evaluate the contractility using positive left ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac resynchronization therapy (CRT).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrophysiological Study | Experimental | Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrophysiological Study | Procedure | Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing | 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. | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maciej Sterlinski, Dr. | Warsaw Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze-Lieve-Vrouwziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| Universitair Ziekenhuis Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29946558 | Derived | Jackson T, Lenarczyk R, Sterlinski M, Sokal A, Francis D, Whinnett Z, Van Heuverswyn F, Vanderheyden M, Heynens J, Stegemann B, Cornelussen R, Rinaldi CA. Left ventricular scar and the acute hemodynamic effects of multivein and multipolar pacing in cardiac resynchronization. Int J Cardiol Heart Vasc. 2018 Apr 10;19:14-19. doi: 10.1016/j.ijcha.2018.03.006. eCollection 2018 Jun. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Patients | Patients who signed informed consent |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eligible Patients | The study enrolled 31 patients of which 30 patients fulfilled the inclusion and exclusion criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing | 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. | 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). | Posted | Mean | Standard Error | percentage change LV dP/dt max | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Patients | Patients who signed informed consent |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shock haemorrhagic | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CRHF Clinical Research | Medtronic, plc | 800-328-2518 | medtroniccrmtrials@medtronic.com |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
| 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 | 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. | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
| Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values | 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. | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
| Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max | 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. | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
| Within Patient Variability in Positive LV dP/dt Max | 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. | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
| Ghent |
| B-9000 |
| Belgium |
| Barzilai Medical Center | Ashkelon | 78278 | Israel |
| Klinika Choroby Wieńcowej | Warsaw | 02-637 | Poland |
| Klinika Zaburzeń Rytmu Serca | Warsaw | 04-628 | Poland |
| Medical University of Silesia | Zabrze | 44-800 | Poland |
| Guys and St. Thomas NHS Trust | London | SE 1 7EH | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W2 I NY | United Kingdom |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing | 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. | 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). | Posted | Mean | Standard Error | percentage change LV dP/dt max | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
|
|
|
| Secondary | 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 | 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. | 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). | Posted | Mean | Standard Error | percentage change LV dP/dt max | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
|
|
|
| Secondary | Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values | 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. | 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. | Posted | Number | Correlation coefficient | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
|
|
|
| Secondary | Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max | 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. | 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. | Posted | Number | 95% Confidence Interval | Kappa statistic | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
|
|
|
| Secondary | Within Patient Variability in Positive LV dP/dt Max | 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. | 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. | Posted | Number | percentage change | Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours |
|
|
|
| 5 |
| 31 |
| 0 |
| 31 |
| Lead dislodgement | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Venous injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
|
| BiV proximal |
|
|
| BiV anterior |
|
|
| BiV posterior |
|
|
| Multivein |
|
|
|
| Title | Measurements |
|---|---|
|
| Diastolic blood pressure (Nexfin system) |
|
| QRS duration ratio |
|
| Q-LV |
|
|
| MultiSpot to BiV mid |
|
|
| MultiSpot to BiV anterior |
|
|
| MultiSpot to BiV posterior |
|
|