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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: October 2, 2012
Last updated: April 19, 2016
Last verified: April 2016
Optimization and evolution of the patient will be evaluated over 6 months after the implant.

Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Optimization method [ Time Frame: From implant procedure until 6 months post-implant ]

    Optimization method. The primary endpoint of this study is to evaluate the usual management (according to the different methods of optimisation used) of patients undergoing Cardiac Resynchronization Therapy (CRT), that have a QuartetTM quadripolar lead with a CRT-D Device implanted during the 6 months post-implant.

    Information about the optimization method used, parameters and variables used with them and number of optimization during 6months post-implant will be collected.

Secondary Outcome Measures:
  • Safety [ Time Frame: From implant procedure until 6 months post-implant ]
    Number of patients with device-related adverse events as a measure of safety, deaths, cardiovascular hospitalizations and hospitalisations for any reason, assessed up to 6 months post-implant.

  • Percentage of responder patients (structural remodelling) [ Time Frame: 6 Months after implant ]
    Structural remodelling is defined as a reduction >15% in End Systolic Volume of the Left Ventricle (LVESV), measured 6months after implant.

  • Demographic data [ Time Frame: Up to 10 days post-implant ]
    Collect demographic information (gender, age, height, weight), medical and cardiovascular history.

  • Treated Ventricular Tachycardia (VT) / Ventricular Fibrillation (VF) episodes incidence [ Time Frame: From implant procedure until 6 months post-implant ]
    Number of treated TV/FV episodes over the 6 months post-implant

Enrollment: 201
Study Start Date: November 2012
Estimated Study Completion Date: October 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Detailed Description:
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01733368

Hospital Universitario Virgen de la Victoria
Málaga, Spain
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Javier Alzueta, MD Hospital Clínico Universitario Virgen de la Victoria
  More Information

Responsible Party: St. Jude Medical Identifier: NCT01733368     History of Changes
Other Study ID Numbers: CR-1 2-015-SP-HF
Study First Received: October 2, 2012
Last Updated: April 19, 2016

Keywords provided by St. Jude Medical:

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 28, 2017