Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population (EFICAZ)

Shock Efficacy, a Randomized Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population

This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.

The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventricular Arrythmia
• Intervention / Treatment: Device: Fixed Tilt (65%); Device: Fixed Pulse Width

• Study Type: Interventional
• Enrollment (Anticipated): 790
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Puerta de Hierro
  • Andalucia
    • Malaga, Andalucia, Spain
      • Hospital Virgen de la Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks

  • Subjects who are willing to be registered on the Merlin.net remote follow-up program
  • Subject ≥18 years
  • Subjects with life expectancy of at least 1 year
  • Subjects who agree to comply with the follow-up program included in this protocol

Exclusion Criteria:

• • Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months

  • Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment
  • Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment
  • Functional NYHA Class IV
  • Subjects who are participating in another ICD or CRT-D study
  • Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives
  • Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fixed Tilt (65%); This is the control group, so device programming for shock energy is the default setting	Device: Fixed Tilt (65%); This is the standard group, so device programming for shock energy is the default setting
Active Comparator: Fixed Pulse Width; This is the Study group.	Device: Fixed Pulse Width; The device has to be programmed with fixed pulse width for each phase of the biphasic waveform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm	Rate of rhythm conversion from Ventricular Tachyarrhythmia to sinus rhythm by the first appropriate shock programmed to 25 Joules (or equivalent voltage) programming the shock waveform in Fixed Pulse Width (Study Group) versus the Fixed Tilt with value 65% (Control Group).	5 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Ignacio Fernandez, MD; Principal Investigator: Javier Alzueta, MD

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CRD_914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No