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

Heart Failure Clinical Trial

— QUARTO-II  

Official title:

Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733368
• Other study ID #: CR-1 2-015-SP-HF
• Status: Completed
• Start date: November 2012
• Est. completion date: August 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after implant
Primary	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)	6 months after implant
Secondary	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.	6 months after implant
Secondary	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.	6 months after implant