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The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by MultiSpot LV pacing (either simultaneously or sequentially) in comparison to the response achieved by the current (standard) BiV pacing configuration in patients indicated/recommended for cardiac resynchronization therapy.
The following pacing configurations will be evaluated.
Biventricular pacing (BiV):
Pacing will be performed on one LV electrode pair, (at 3 different longitudinal locations), and on the tip of the RV-lead. In total, three different pacing BiV settings will be evaluated. Configuration 1: RV + LV lateral Apex, Configuration 2: RV + LV lateral Mid, Configuration 3: RV + LV lateral Base (Reference: Standard CRT)
MultiSpot simultaneous LV-ventricular pacing (MultiSpot-SYN):
Pacing will be performed on 3 electrodes on the LV wall, placed at different longitudinal locations, and on the tip of the RV-lead simultaneously. Configuration 4: RV + LV lateral Apex + LV lateral Mid + LV lateral Base
MultiSpot sequential LV-ventricular pacing (MultiSpot-SEQ):
3 electrodes on the LV wall will be paced sequentially. The RV electrode will be paced simultaneously with last paced LV electrode.The timing-sequence and the amount of spots will depend on the electrical delays measured during the experiments. Configuration 5: LV lateral Apex => LV lateral Mid => LV lateral Base + RV
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| 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 during electrophysiological study procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec) | LV dP/dt max is a measurement of the initial velocity of myocardial contraction and is derivative of the LV-pressure. 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 were followed for the time of the EP procedure, which had a median duration of 48 min |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure | Measured by invasive arterial blood line connected to a sensitive membrane displacement sensor. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected.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 pressure during pacing On] - (median pressure during pacing Off])/[median pressure during pacing Off]. 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. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Choroby Wieńcowej | Warsaw | Poland | ||||
| Medical University of Silesia, Silesian Center for Heart Disease, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35647062 | Derived | Sterlinski M, Zakrzewska-Koperska J, Maciag A, Sokal A, Osca-Asensi J, Wang L, Spyropoulou V, Maus B, Lemme F, Okafor O, Stegemann B, Cornelussen R, Leyva F. Acute Hemodynamic Effects of Simultaneous and Sequential Multi-Point Pacing in Heart Failure Patients With an Expected Higher Rate of Sub-response to Cardiac Resynchronization Therapy: Results of Multicenter SYNSEQ Study. Front Cardiovasc Med. 2022 May 12;9:901267. doi: 10.3389/fcvm.2022.901267. eCollection 2022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Electrophysiological Study | Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure. Electrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled patient except patient with protocol deviation (subject was not eligible for study)
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| ID | Title | Description |
|---|---|---|
| BG000 | Electrophysiological Study | Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure. Electrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure. |
| 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 | Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec) | LV dP/dt max is a measurement of the initial velocity of myocardial contraction and is derivative of the LV-pressure. 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. | The analysis population contains all subjects who completed electrophysiological study with analyzable data. For some patients not all pacing configurations were applied. Two patients missed Multispot sequential pacing and one patient missed BiV mid pacing. | Posted | Mean | Standard Error | % change LV dP/dt max | Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
Adverse events were collected from enrollment to study exit. Follow-up time (enrollment to exit) for subjects varied from 1 to 113 days.
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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 | Enrolled Subjects | All patients that signed informed consent will be summarized |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac vein dissection | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Cornelussen | Medtronic Bakken Research Center | +31433566651 | richard.cornelussen@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2016 | Jul 20, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 22, 2015 | Jul 24, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
| Correlation Between Percentage Change LV dP/dt Max and Percentage Change Non-Invasive Blood Pressure | Acquired through finger volume clamp | Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
| Correlation Between Percentage Change LV dP/dt Max and Q-LV Ratio | Derived from intra-cardiac leads (invasive) and surface electrodes (non-invasive) respectively. The Q-LV interval is defined as the time from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV electrogram (EGM) during a cardiac cycle. The Q-LV ratio will be calculated as Q-LV/QRS duration. Correlation will be summarized over all pacing configurations since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation between % change LV dP/dt max and Q-LV ratio. | Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
| Correlation Between Percentage Change LV dP/dt Max and % Change QRS Width | Derived from surface electrodes (non-invasive). The percentage change is determined as ([QRS width during pacing On] - (QRS width during pacing Off])/[QRS width during pacing Off]. The correlation between % change LV dP/dt max and % change QRS width will be summarized over all pacing configurations 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. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation. | Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
| Zabrze |
| Poland |
| Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH) | Bratislava | Slovakia |
| Východoslovenský ústav srdcových a cievnych chorôb, a.s. (VUSCH) | Košice | Slovakia |
| Hospital Universitari I Politècnic La Fe | Valencia | Spain |
| Skåne University Hospital | Lund | Sweden |
| Queen Elizabeth Medical Centre | London | United Kingdom |
| Electrical instability of patient |
|
| ECG acquisition error due to sweating |
|
| Protocol Violation |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Electrophysiological Study | Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure. Electrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure. |
|
|
| Secondary | Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure | Measured by invasive arterial blood line connected to a sensitive membrane displacement sensor. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected.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 pressure during pacing On] - (median pressure during pacing Off])/[median pressure during pacing Off]. 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. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation. | All patients with analyzable LV dP/dt max data and analyzable and/or available blood pressure data. Two patients of the 25 patients with analyzable LV dP/dt max data did not have blood pressure data available or analyzable. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
|
|
|
| Secondary | Correlation Between Percentage Change LV dP/dt Max and Percentage Change Non-Invasive Blood Pressure | Acquired through finger volume clamp | The collection of non-invasive blood pressures was optional. During study execution, it was decided to not collect and/or analyze any non-invasive blood pressures. | Posted | Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
|
|
| Secondary | Correlation Between Percentage Change LV dP/dt Max and Q-LV Ratio | Derived from intra-cardiac leads (invasive) and surface electrodes (non-invasive) respectively. The Q-LV interval is defined as the time from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV electrogram (EGM) during a cardiac cycle. The Q-LV ratio will be calculated as Q-LV/QRS duration. Correlation will be summarized over all pacing configurations since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation between % change LV dP/dt max and Q-LV ratio. | The analysis population contains all subjects who completed electrophysiological study with analyzable data. For five patients no Q-LV timings were available for analysis. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
|
|
|
| Secondary | Correlation Between Percentage Change LV dP/dt Max and % Change QRS Width | Derived from surface electrodes (non-invasive). The percentage change is determined as ([QRS width during pacing On] - (QRS width during pacing Off])/[QRS width during pacing Off]. The correlation between % change LV dP/dt max and % change QRS width will be summarized over all pacing configurations 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. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation. | The analysis population contains all subjects who completed electrophysiological study with analyzable data. For one patient no QRS width was available for analysis. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Participants were followed for the time of the EP procedure, which had a median duration of 48 min |
|
|
|
| 0 |
| 31 |
| 3 |
| 31 |
| 2 |
| 31 |
| Coronary artery disease | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Lead dislogdement | General disorders | MedDRA (18.1) | Systematic Assessment |
|
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