Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population (EFICAZ)
Primary Purpose
Ventricular Arrythmia
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Fixed Tilt (65%)
Fixed Pulse Width
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Arrythmia
Eligibility Criteria
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)
Sites / Locations
- Hospital Virgen de la Victoria
- Hospital Puerta de Hierro
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fixed Tilt (65%)
Fixed Pulse Width
Arm Description
This is the control group, so device programming for shock energy is the default setting
This is the Study group.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03632057
Brief Title
Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
Acronym
EFICAZ
Official Title
Shock Efficacy, a Randomized Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
790 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fixed Tilt (65%)
Arm Type
Active Comparator
Arm Description
This is the control group, so device programming for shock energy is the default setting
Arm Title
Fixed Pulse Width
Arm Type
Active Comparator
Arm Description
This is the Study group.
Intervention Type
Device
Intervention Name(s)
Fixed Tilt (65%)
Intervention Description
This is the standard group, so device programming for shock energy is the default setting
Intervention Type
Device
Intervention Name(s)
Fixed Pulse Width
Intervention Description
The device has to be programmed with fixed pulse width for each phase of the biphasic waveform
Primary Outcome Measure Information:
Title
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm
Description
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).
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio Fernandez, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Alzueta, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Virgen de la Victoria
City
Malaga
State/Province
Andalucia
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
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