QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead

N/ACompletedNCT01733368

Abbott Medical Devices198 enrolled

Overview

Optimization and evolution of the patient will be evaluated over 6 months after the implant.

Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.

Study Type

OBSERVATIONAL

Enrollment

198

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle. * Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured * Patients who have granted their informed consent. * Patients above 18 years. Exclusion Criteria: * Patients that have been previously resynchronized. * Patients with aortic stenosis or aortic valve prosthesis * Patients who are or may potentially be pregnant. * Patients with a life expectancy \<12 months. * Patients who cannot attend the monitoring visits established by the protocol.

Locations (1)

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Outcomes

Primary Outcomes

Number of Responder Patients (Structural Remodelling)

Structural remodelling is defined as a reduction \>15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.

Time frame: 6 months after implant

Safety Outcomes in CRT Responders and Non-Responders

* Mortality rate, * Rate of cardiovascular hospitalizations and for any cause or * Combined endpoint (death and all-cause hospitalization)

Time frame: 6 months after implant

Secondary Outcomes

Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector

Response is defined as a reduction \>15% in LVESV, measured 6 months after implant. Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.

Time frame: 6 months after implant

Number of Responder Patients With Conventional Left Ventricular Pacing Vector

Response is defined as a reduction \>15% in LVESV, measured 6 months after implant. Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.

Time frame: 6 months after implant

Data from ClinicalTrials.gov

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