NCT02914457

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2016

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 7, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 14, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

June 8, 2016

Results QC Date

August 3, 2020

Last Update Submit

September 3, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure

    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

    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

    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

    Participants were followed for the time of the EP procedure, which had a median duration of 48 min

Study Arms (1)

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.

Procedure: Electrophysiological Study

Interventions

Electrophysiological StudyPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Klinika Choroby Wieńcowej

Warsaw, Poland

Location

Medical University of Silesia, Silesian Center for Heart Disease,

Zabrze, Poland

Location

Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH)

Bratislava, Slovakia

Location

Východoslovenský ústav srdcových a cievnych chorôb, a.s. (VUSCH)

Košice, Slovakia

Location

Hospital Universitari I Politècnic La Fe

Valencia, Spain

Location

Skåne University Hospital

Lund, Sweden

Location

Queen Elizabeth Medical Centre

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35647062DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Richard Cornelussen
Organization
Medtronic Bakken Research Center
richard.cornelussen@medtronic.com
+31433566651

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

September 26, 2016

Study Start

November 7, 2016

Primary Completion

April 20, 2018

Study Completion

April 20, 2018

Last Updated

September 25, 2020

Results First Posted

August 14, 2020

Record last verified: 2020-09

Locations

ES(1)GB(1)SE(1)SL(2)PL(2)