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

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.

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

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