Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: MPP ON


Participation Criteria
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Eligibility Criteria
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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.-

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPP ON<br>To activate the Multipoint Pacing (MPP) feature to ON in all patients | Device: MPP ON<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cardiac Resynchronization Therapy, Quadripolar Left Ventricular Lead, Multipoint Pacing, Hemodynamic Response