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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MPP ON
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Cardiac Resynchronization Therapy, Quadripolar Left Ventricular Lead, Multipoint Pacing, Hemodynamic Response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.-

Sites / Locations

  • Hospital Virgen de la Victoria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MPP ON

Arm Description

To activate the Multipoint Pacing (MPP) feature to ON in all patients

Outcomes

Primary Outcome Measures

Number of CRT Responders
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

Changes in LV Echocardiographic Parameters
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.
Number of CRT Super-responders
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.
Rates of Hospitalization and Mortality
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.
Change in NYHA Classification
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.

Full Information

First Posted
June 16, 2015
Last Updated
February 18, 2022
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02476201
Brief Title
Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)
Acronym
QUARTO_III
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Cardiac Resynchronization Therapy, Quadripolar Left Ventricular Lead, Multipoint Pacing, Hemodynamic Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MPP ON
Arm Type
Experimental
Arm Description
To activate the Multipoint Pacing (MPP) feature to ON in all patients
Intervention Type
Device
Intervention Name(s)
MPP ON
Intervention Description
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 Measure Information:
Title
Number of CRT Responders
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in LV Echocardiographic Parameters
Description
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.
Time Frame
Baseline and 6 months
Title
Number of CRT Super-responders
Description
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.
Time Frame
6 months
Title
Rates of Hospitalization and Mortality
Description
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.
Time Frame
6 months
Title
Change in NYHA Classification
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Sanz
Organizational Affiliation
Abbott Medical
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Virgen de la Victoria
City
Malaga
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)

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