RESponders and QUadripolar LV Lead in CRT

• Conditions: Heart Failure

• Registration Number: NCT02433756
• Lead Sponsor: Ospedale Santa Croce-Carle Cuneo

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months	6-Months
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months	12-Months

Secondary Outcome Measures

Name	Time	Method
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months	18 months

Trial Locations

Locations (3)

S.Croce e Carle Hospital; 🇮🇹 Cuneo, Italy

Ciriè Hospital; 🇮🇹 Ciriè, Italy

Maria Vittoria Hospital; 🇮🇹 Torino, Italy