Quartet Lead and Resynchronization Therapy Options 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.

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.

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.-