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Completed

NCT Number: NCT02476201

Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)

The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Virgen de la Victoria

Málaga, Spain

About this study

The primary endpoint of the study is to measure prospectively at 6 months the percentage of responder* patients implanted with a Quartet LV quadripolar lead and with the MultiPoint Pacing feature activated compared with No Pacing at baseline.

*A positive CRT response is defined as an improvement of more than 15 % in Left Ventricular End Systolic Volume (LVESV) at 6 months post-implant, measured by Echocardiography.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient that will be implanted with a Cardiac Resynchronization Therapy (CRT-D) with the MultiPoint Pacing (MPP) feature under the current Guidelines indications for CRT-D implant (including upgrades from single or dual chamber Defibrillator or Pacemaker).
  • Patient that will be implanted with a Quartet Left Ventricular (LV) quadripolar lead.
  • In sinus rhythm at baseline visit.
  • Patients with Left Bundle Branch Block (LBBB)
  • Must be willing and able to comply with study requirements.
  • Older than 18 years
  • Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form.

Exclusion criteria

  • Already has a CRT device implanted.
  • Myocardial Infarction or unstable angina within 40 days prior the enrollment.
  • New York Heart Association (NYHA) Class IV
  • Recent cardiac revascularization in the 4 weeks prior to enrollment.
  • Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment.
  • Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months.
  • Primary valvular disease requiring surgical intervention.
  • Atrial Fibrillation (AF):
  • Persistent AF at the time of enrollment or 30 days prior the enrollment
  • Permanent AF not treated with Atrio-Ventricular node ablation within 2 weeks after the CRT-D implant
  • History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
  • Patient for whom suitable Transthoracic echocardiographic images for determining the cardiac output (CO) and LV volumes cannot be obtained.
  • Undergone a cardiac transplantation or being waiting for it
  • Life expectancy < 6 months
  • Pregnancy or planning to become pregnant
  • Unable to comply with the follow up schedule
  • Currently participating in any other clinical investigation.-

Treatment and study plan

MPP ON

Device

Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated

Primary outcomes

  1. Number of CRT Responders

    Time frame: 6 months

    The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of >15 % in LVESV, as measured by echocardiography.

Secondary outcomes

  1. Changes in LV Echocardiographic Parameters

    Time frame: Baseline and 6 months

    An echocardiogram was performed at baseline and at 6 months in subjects with MPP activated. The outcome evaluated the percentage of change in LVESV, left ventricular end-diastolic volume (LVEDV), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) as compared to baseline prior to implant.

    The values of change with positive numbers represent increases and negative numbers represent decreases.

  2. Number of CRT Super-responders

    Time frame: 6 months

    The outcome evaluated the number of CRT super-responders at 6 months in subjects with MPP activated. A super-responder is defined as a subject with a mean absolute LVEF increase of >14% at 6 months post-implant compared to baseline.

  3. Rates of Hospitalization and Mortality

    Time frame: 6 months

    The outcome measures rates of all-cause mortality, all-cause hospitalization, cardiovascular hospitalization, and heart failure hospitalization. In addition, the outcome measures the combined endpoint of mortality and heart failure hospitalization and mortality and cardiovascular hospitalization. For the combined endpoints, if a participant experienced both endpoints, they were counted as one participant.

  4. Change in NYHA Classification

    Time frame: 6 months

    The outcome measures status changes in NYHA classification at 6 months for subjects with MPP activated. Subjects experienced either an improvement, worsening, or no change in NYHA classification.

    The NYHA provides a simple way of classifying the extent of heart failure:

    NYHA I: No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation, dyspnea.

    NYHA II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea.

    NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Quartet Lead and Resynchronization Therapy Options - Assessing the Response Rate at 6 Months in CRT Patients Implanted With a Quartet Left Ventricular(LV) Quadripolar Lead and the MultiPoint Pacing (MPP) Feature Activated

Acronym: QUARTO_III

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2015
Registry last updated
Mar 2, 2022

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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