RESponders and QUadripolar LV Lead in CRT

Responders and Quadripolar LV Lead in CRT

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02433756

Acronym

ResQ CRT

Enrollment

180

Registered

2015-05-05

Start date

2013-03-31

Completion date

2016-05-31

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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).

Interventions

DEVICECRTD

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026