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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2018-04-20

Brief Summary

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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.

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Detailed Description

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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

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Electrophysiological Study

Intervention Type PROCEDURE

Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No