Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)

NCT ID: NCT02476201

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-07-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MPP ON

To activate the Multipoint Pacing (MPP) feature to ON in all patients

Group Type: EXPERIMENTAL

MPP ON

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oscar Sanz

Role: STUDY_DIRECTOR

Abbott Medical

Locations

Hospital Virgen de la Victoria

Málaga, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRD_789

Identifier Type: -

Identifier Source: org_study_id