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

Completed

• Conditions: Heart Failure

• Registration Number: NCT01733368
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-10-02
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-27
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Results First Submitted: 2017-05-31
• Results First Submitted QC: 2018-02-26
• Results First Posted: 2018-03-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Outcomes in CRT Responders and Non-Responders	6 months after implant	* Mortality rate,; * Rate of cardiovascular hospitalizations and for any cause or; * Combined endpoint (death and all-cause hospitalization)
Number of Responder Patients (Structural Remodelling)	6 months after implant	Structural remodelling is defined as a reduction \>15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.

Secondary Outcome Measures

Name	Time	Method
Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector	6 months after implant	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.
Number of Responder Patients With Conventional Left Ventricular Pacing Vector	6 months after implant	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.

Trial Locations

Locations (1)

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain