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

NCT ID: NCT01733368

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-08-31

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Alzueta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Virgen de la Victoria

Locations

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Countries

Spain

Other Identifiers

CR-1 2-015-SP-HF

Identifier Type: -

Identifier Source: org_study_id