Heart FailureSYNSEQNCT02914457
Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)
A study testing Electrophysiological Study in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Electrophysiological Study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 7 Nov 2016to 20 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Poland2 sites
Klinika Choroby Wieńcowej
Warsaw
Medical University of Silesia, Silesian Center for Heart Disease,
Zabrze
Slovakia2 sites
Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH)
Bratislava
Východoslovenský ústav srdcových a cievnych chorôb, a.s. (VUSCH)
Košice
About this study
Official title: 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.
Read the 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
- Conditions
- Heart Failure
- Being tested
- Electrophysiological Study
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological StudyProcedure or surgery
Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Electrophysiological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start7 Nov 2016
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914457
- Sponsor's protocol ID
- SYNSEQ
- Acronym
- SYNSEQ
- Status last verified
- Sep 2020
- First submitted
- 8 Jun 2016
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35647062
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for CRT
- ClinicalTrials.gov ID
- NCT02914457
- Acronym / sponsor ID
- SYNSEQ / SYNSEQ
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 14 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrophysiological Study | Experimental | Procedure: Electrophysiological StudySubjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiological StudySubjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure. | Procedure or surgery | Electrophysiological Study |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35647062Sterlinski 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological Study in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland, Slovakia, Spain, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.