Responders and Quadripolar LV Lead in CRT
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 180
- Locations
- 3
- Primary Endpoint
- Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be in NYHA II, III or IV functional class with approved standard indication by ESC/EHRA Guidelines
- •Successful quadripolar LV lead implant
Exclusion Criteria
- •Less than 18 years of age
- •Epicardial Lead
- •Life expectancy < 12 months
- •Pregnant or are planning to become pregnant during the duration of the investigation
Outcomes
Primary Outcomes
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months
Time Frame: 6-Months
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months
Time Frame: 12-Months
Secondary Outcomes
- Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months(18 months)
Investigators
Antonello Vado
MD
Ospedale Santa Croce-Carle Cuneo