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

Ventricular Arrythmia Clinical Trial

— EFICAZ  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03632057
• Other study ID #: CRD_914
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: May 2025

Study information

• Verified date: April 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 790
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ventricular Arrythmia

Intervention

Device:
• Fixed Tilt (65%)
This is the standard group, so device programming for shock energy is the default setting
• Fixed Pulse Width
The device has to be programmed with fixed pulse width for each phase of the biphasic waveform

Locations

Country	Name	City	State
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Virgen de la Victoria	Malaga	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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