Clinical trial NCT02914457: Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)
Official title: Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for CRT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec)
timeFrame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
Secondary outcomes:
measure: Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure
timeFrame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
measure: Correlation Between Percentage Change LV dP/dt Max and Percentage Change Non-Invasive Blood Pressure
timeFrame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
measure: Correlation Between Percentage Change LV dP/dt Max and Q-LV Ratio
timeFrame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
measure: Correlation Between Percentage Change LV dP/dt Max and % Change QRS Width
timeFrame: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Klinika Choroby Wieńcowej
city: Zabrze
country: Poland
facility: Medical University of Silesia, Silesian Center for Heart Disease,
city: Bratislava
country: Slovakia
facility: Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH)
city: Košice
country: Slovakia
facility: Východoslovenský ústav srdcových a cievnych chorôb, a.s. (VUSCH)
city: València
country: Spain
facility: Hospital Universitari I Politècnic La Fe
city: Lund
country: Sweden
facility: Skåne University Hospital
city: London
country: United Kingdom
facility: Queen Elizabeth Medical Centre
Study officials:
References:
citation: 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.