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Completed

NCT Number: NCT01733368

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Responder Patients (Structural Remodelling)

    Time frame: 6 months after implant

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

  2. Safety Outcomes in CRT Responders and Non-Responders

    Time frame: 6 months after implant

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

Secondary outcomes

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

    Time frame: 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.

  2. Number of Responder Patients With Conventional Left Ventricular Pacing Vector

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: QUARTO-II

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Nov 27, 2012
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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