Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-02 @ 1:11 PM
Study NCT ID:
NCT02433756
Status:
UNKNOWN
Last Update Posted:
2016-03-31
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESponders and QUadripolar LV Lead in CRT
Sponsor:
Ospedale Santa Croce-Carle Cuneo
Organization:
Study Overview
Official Title:
Responders and Quadripolar LV Lead in CRT
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
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:
ResQ CRT
Brief Summary:
The purpose of this study is to observe the evolution of the CRTD system with left quadripolar lead, in terms of electrical parameters in all pacing configurations and to evaluate the impact on the clinical outcome.
Detailed Description:
Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders.
Pacing activation from proximal area with a left quadripolar lead might improve the depolarization pattern.
To explore the effect of CRT pacing on cardiac activity, the investigators will enroll approximately 180 patients who already underwent CRT-D implantation with a quadripolar LV lead.
After implant, as clinical practice, the device will be programmed with distal LV pacing configuration, after 6 months in patient non-responders to CRT therapy the pacing configuration will be changed (proximal configuration).
After 12 months in patients non-responders will be changed the pacing configuration again, choosing, if it is possible, a multi point pacing (pacing activation from multiple separated left ventricular (LV) sites).
Pacing activation from proximal area with a left quadripolar lead might improve the depolarization pattern.
To explore the effect of CRT pacing on cardiac activity, the investigators will enroll approximately 180 patients who already underwent CRT-D implantation with a quadripolar LV lead.
After implant, as clinical practice, the device will be programmed with distal LV pacing configuration, after 6 months in patient non-responders to CRT therapy the pacing configuration will be changed (proximal configuration).
After 12 months in patients non-responders will be changed the pacing configuration again, choosing, if it is possible, a multi point pacing (pacing activation from multiple separated left ventricular (LV) sites).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: