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Quartet Lead and Resynchronization Therapy Options III (QUARTO III) (QUARTO III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02476201
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: MPP ON Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 2016
Actual Primary Completion Date : February 13, 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: MPP ON
To activate the Multipoint Pacing (MPP) feature to ON in all patients
Device: MPP ON
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 Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476201


Locations
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Spain
Hospital Virgen de la Victoria
Malaga, Spain
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Oscar Sanz Abbott Medical
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02476201    
Other Study ID Numbers: CRD_789
First Posted: June 19, 2015    Key Record Dates
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abbott Medical Devices:
Heart Failure
Cardiac Resynchronization Therapy
Quadripolar Left Ventricular Lead
Multipoint Pacing
Hemodynamic Response
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases