search
Back to results

Left Ventricular MultiSpot Pacing for CRT (iSPOT) (iSPOT)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Electrophysiological Study
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is indicated for cardiac CRT or CRT-D device according to current applicable European Society of Cardiology (ESC)/American Heart Association (AHA) guidelines
  • Subject has a left bundle branch block (LBBB) conduction pattern
  • Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion and no documented atrial fibrillation (AF) episodes allowed during the last 2 weeks prior to inclusion)
  • Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or angiotensin receptor blockers (ARB) and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
  • Subject (or the legal guardian) is willing to sign informed consent form
  • Subject is 18 years or older or as specified minimal age per local law/regulation

Exclusion Criteria:

  • Subject has permanent atrial fibrillation/ flutter or tachycardia
  • Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
  • Subject underwent coronary artery bypass graft (CABG) or 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 left ventricular assist device (LVAD)
  • Subject is on chronic renal dialysis
  • Subject has severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) < 30 mL/min/1.73m2)
  • Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
  • Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
  • Subject has complex and uncorrected congenital heart disease
  • Subject has a mechanical heart valve
  • Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
  • Subject is enrolled in one or more concurrent studies that would confound the results of this study
  • Subject is already implanted with a device

Sites / Locations

  • Onze-Lieve-Vrouwziekenhuis Aalst
  • Universitair Ziekenhuis Gent
  • Barzilai Medical Center
  • Klinika Choroby Wieńcowej
  • Klinika Zaburzeń Rytmu Serca
  • Medical University of Silesia
  • Guys and St. Thomas NHS Trust
  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrophysiological Study

Arm Description

Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
May 24, 2013
Last Updated
May 28, 2018
Sponsor
Medtronic Bakken Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01883141
Brief Title
Left Ventricular MultiSpot Pacing for CRT (iSPOT)
Acronym
iSPOT
Official Title
Left Ventricular MultiSpot Pacing for CRT (iSPOT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrophysiological Study
Arm Type
Experimental
Arm Description
Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure
Intervention Type
Procedure
Intervention Name(s)
Electrophysiological Study
Intervention Description
Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots
Primary Outcome Measure Information:
Title
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
Description
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.
Time Frame
Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
Secondary Outcome Measure Information:
Title
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing
Description
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.
Time Frame
Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
Title
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
Description
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.
Time Frame
Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
Title
Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values
Description
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.
Time Frame
Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
Title
Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max
Description
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.
Time Frame
Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
Title
Within Patient Variability in Positive LV dP/dt Max
Description
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.
Time Frame
Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is indicated for cardiac CRT or CRT-D device according to current applicable European Society of Cardiology (ESC)/American Heart Association (AHA) guidelines Subject has a left bundle branch block (LBBB) conduction pattern Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion and no documented atrial fibrillation (AF) episodes allowed during the last 2 weeks prior to inclusion) Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or angiotensin receptor blockers (ARB) and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment Subject (or the legal guardian) is willing to sign informed consent form Subject is 18 years or older or as specified minimal age per local law/regulation Exclusion Criteria: Subject has permanent atrial fibrillation/ flutter or tachycardia Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment Subject underwent coronary artery bypass graft (CABG) or 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 left ventricular assist device (LVAD) Subject is on chronic renal dialysis Subject has severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) < 30 mL/min/1.73m2) Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week) Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period) Subject has complex and uncorrected congenital heart disease Subject has a mechanical heart valve Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control Subject is enrolled in one or more concurrent studies that would confound the results of this study Subject is already implanted with a device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej Sterlinski, Dr.
Organizational Affiliation
Warsaw Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze-Lieve-Vrouwziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Klinika Choroby Wieńcowej
City
Warsaw
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Klinika Zaburzeń Rytmu Serca
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Medical University of Silesia
City
Zabrze
ZIP/Postal Code
44-800
Country
Poland
Facility Name
Guys and St. Thomas NHS Trust
City
London
ZIP/Postal Code
SE 1 7EH
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 I NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29946558
Citation
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. Erratum In: Int J Cardiol Heart Vasc. 2020 Dec 19;32:100698.
Results Reference
derived

Learn more about this trial

Left Ventricular MultiSpot Pacing for CRT (iSPOT)

We'll reach out to this number within 24 hrs