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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: MPP ON

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Malaga, Spain
    • Hospital Virgen de la Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 6 months
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.	6 months
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.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Oscar Sanz, Abbott Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac Resynchronization Therapy; Hemodynamic Response; Quadripolar Left Ventricular Lead; Multipoint Pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CRD_789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No