Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT) (SYNSEQ)

September 3, 2020 updated by: Medtronic Cardiac Rhythm and Heart Failure

Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for CRT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • 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

  • Poland
      • Warszawa, Poland
        • Klinika Choroby Wieńcowej
      • Zabrze, Poland
        • Medical University of Silesia, Silesian Center for Heart Disease,
  • Slovakia
      • Bratislava, Slovakia
        • Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
      • Košice, Slovakia
        • Východoslovenský ústav srdcových a cievnych chorôb, a.s. (VUSCH)
  • Spain
      • València, Spain
        • Hospital Universitari i Politècnic La Fe
  • Sweden
      • Lund, Sweden
        • Skåne University Hospital
  • United Kingdom
      • London, United Kingdom
        • Queen Elizabeth Medical Centre

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is indicated or recommended for CRT-P or CRT-D device according to current applicable ESC/AHA guidelines
  • Subject is in sinus rhythm
  • Subject receives optimal heart failure oral medical therapy
  • Subject is willing to sign the informed consent form
  • Subject is 18 years or older

Exclusion Criteria:

  • Subject has permanent atrial fibrillation/flutter or tachycardia
  • Subject has pure right bundle branch block (= no additional left ventricular conduction delays)
  • Subject has left bundle branch block and QRS-duration of > 150 ms and no sign of myocardial scar indicated by late gadolinium enhancement MRI
  • Subject experienced recent myocardial infarction, within 40 days prior to enrollment
  • Subject underwent 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
  • Subject has severe renal disease (up to physicians discretion)
  • 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 another study that could confound the results of this study, without documented pre-approval from Medtronic study manager

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 during electrophysiological study procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec)
Time Frame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure
Time Frame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
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.
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
Time Frame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
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
Time Frame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
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
Time Frame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
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

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

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 (Actual)

November 7, 2016

Primary Completion (Actual)

April 20, 2018

Study Completion (Actual)

April 20, 2018

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNSEQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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