Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476201
• Other study ID #: CRD_789
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2019

Study information

• Verified date: February 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.-

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Virgen de la Victoria	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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