Quartet Lead and Resynchronization Therapy Options III (QUARTO III) (QUARTO III)
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|ClinicalTrials.gov Identifier: NCT02476201|
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: MPP ON||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Hospital Virgen de la Victoria|
|Study Director:||Oscar Sanz||Abbott Medical|