Clinical trial NCT02476201: Quartet Lead and Resynchronization Therapy Options III (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Cardiac Resynchronization Therapy
Quadripolar Left Ventricular Lead
Multipoint Pacing
Hemodynamic Response
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-06-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.-

Primary outcomes:
measure: Number of CRT Responders
timeFrame: 6 months
Secondary outcomes:
measure: Changes in LV Echocardiographic Parameters
timeFrame: Baseline and 6 months
measure: Number of CRT Super-responders
timeFrame: 6 months
measure: Rates of Hospitalization and Mortality
timeFrame: 6 months
measure: Change in NYHA Classification
timeFrame: 6 months
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
Study officials:
affiliation: Abbott Medical
name: Oscar Sanz
role: STUDY_DIRECTOR
References: