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

June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Onze-Lieve-Vrouwziekenhuis Aalst
      • Gent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
  • Israel
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center
  • Poland
      • Warsaw, Poland, 02-637
        • Klinika Choroby Wieńcowej
      • Warsaw, Poland, 04-628
        • Klinika Zaburzeń Rytmu Serca
      • Zabrze, Poland, 44-800
        • Medical University of Silesia
  • United Kingdom
      • London, United Kingdom, SE 1 7EH
        • Guys and St. Thomas NHS Trust
      • London, United Kingdom, W2 I NY
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Procedure: Electrophysiological Study
Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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
Time Frame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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
Time Frame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
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.
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
Time Frame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
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
Time Frame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
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
Time Frame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
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
Time Frame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maciej Sterlinski, Dr., Warsaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • iSPOT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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