NCT02433756

RESponders and QUadripolar LV Lead in CRT

Responders and Quadripolar LV Lead in CRT

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Ospedale Santa Croce-Carle Cuneo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	CRTD

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2015-05-05
• Last updated: 2016-03-31

Locations

3 sites across 1 country: Italy