NCT02914457

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

Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for CRT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2016-11-07
• Primary completion: 2018-04-20
• Completion: 2018-04-20
• First posted: 2016-09-26
• Last updated: 2020-09-25
• Results posted: 2020-08-14

Locations

7 sites across 5 countries: Poland, Slovakia, Spain, Sweden, United Kingdom