Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-03 @ 11:08 PM
Study NCT ID:
NCT02914457
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Study Overview
Official Title:
Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for CRT
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYNSEQ
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: