Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)

NCT02476201 | Completed Results

• 1 other identifier: CRD_789
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Cardiac Resynchronization Therapy; Quadripolar Left Ventricular Lead; Multipoint Pacing; Hemodynamic Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in LV Echocardiographic Parameters

  Baseline and 6 months

• Number of CRT Super-responders

  6 months

• Rates of Hospitalization and Mortality

  6 months

• Change in NYHA Classification

  6 months

Study Arms (1)

MPP ON

EXPERIMENTAL

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

Device: MPP ON

Interventions

MPP ON 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

MPP ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Hospital Virgen de la Victoria

Málaga, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Pilar Santamaria
• Organization: Abbott Medical

pilar.santamaria@abbott.com

+34 917 278 964

Study Officials

• Oscar Sanz

  Abbott Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 19, 2015
• Study Start: February 1, 2016
• Primary Completion: February 13, 2019
• Study Completion: July 1, 2019
• Last Updated: March 2, 2022
• Results First Posted: August 3, 2020

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)