Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)

Abbott

Status

Completed

Conditions

Heart Failure

Treatments

Device: MPP ON

Study type

Interventional

Funder types

Industry

Identifiers

NCT02476201

CRD_789

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.-